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DART provides nearly five million rides to central Iowa residents and visitors each year. Our services benefit both those who ride DART and those who do not by helping to strengthen local communities and the economy. A strong public transit system benefits the communities it serves in several ways.
Top five reasons people ride DART
DART's services ensure everyone in our region has access to opportunity. For some central Iowans, transit is the only means they have to get to work, medical appointments, school and more.
Our diverse group of riders range in age, socio-economic status and dependency on transit. DART conducts a survey of our riders biannually to learn how we are meeting their needs. This survey also allows us to collect some demographic information so we understand who we are serving.
Economic Vitality
DART helps to make Greater Des Moines competitive and drives the possibilities for our region and the communities we serve. A strong public transit system supports job creation and retention and fosters economic activity. This includes:
Every $1 invested in transit results in $4 in economic development.*
87 percent of public transit trips directly benefit the economy, with riders spending or making money. **
DART works with our member communities and local private and public partners to ensure that our region remains a great place to live, work and play. Through partnerships, DART has managed to expand its transit network to offer rides to new areas of our region without increasing property taxes.
By 2040, Greater Des Moines' population is expected to reach 1 million. In that same time, we will experience a 40% increase in jobs. This is why it's so important to put the right infrastructure in place to support this growth, and keep our region a top place to live, work and play.
Through investing in our local infrastructure by strengthening public transit we will be able to help mitigate challenges. For example, investing in public transit can help to reduce the number of commuters driving, helping to maintain commute times.
* American Public Transportation Association (APTA), "Economic Recovery: Promoting Growth the Benefits of Public Transportation"
** American Public Transportation Association (APTA), "Nearly 90% of Public Transit Trips Impact Economy Through Work Commute and Consumer Spending"
"Access to transit not only helps the environment by keeping more cars off the road, it keeps people from having to take lower paying jobs because they can't get to where the higher paying jobs are at."
Brandy, DART rider who lives in Des Moines and travels to her job at Jordan Creek Town Center in West Des Moines on transit.
"For me, it makes sense to take the bus. Paying less than $50 a month for a bus pass is much more affordable than a car payment, car insurance and gas every month."
Erik, DART rider who works full-time overnights and attends college at DMACC in Ankeny part-time.
"I love how DART is free for veterans now. It used to cost me $4 a day to get from Urbandale to Ankeny for school every day."
Lindsey, DART rider and Veteran who rides DART to school and to work.
"I try to use my car as little as possible because it feels good to know I'm not contributing to traffic or pollution."
Kerri, DART rider
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ROME, Jun 12 2017 (IPS) - Globally over 1.5 billion people live in countries that are affected by conflict, violence and fragility. Meantime, around 200 million people are affected by disasters every year—a third of them are children. And a significant proportion of the 168 million children engaged in child labour live in areas affected by conflict and disaster. These are the facts. Up to you to reflect on the immediate future of humankind.
Conflicts and disasters have a devastating impact on people's lives, the United Nations reminds.
Of this total of 168 million children victims of modern slavery, about 100 million boys and 68 million girls.
Forced labour is estimated to generate around 150 billion dollars a year in illegal profits.
Amid such a huge human tragedy, children are often the first to suffer as schools are destroyed and basic services are disrupted, the world body reports.
This why on the occasion of the 2017 World Day Against Child Labour, marked June 12, the UN focuses on the impact of conflicts and disasters on child labour.
Child Labour No More by 2025?
Child labour and forced labour in conflicts and humanitarian settings will be discussed at the IV Global Conference on Child Labour (Buenos Aires, 14-16 November 2017).
For its part, the UN Children Fund (UNICEF) warns that child labour deprives children of their right to go to school, exposes them to violence, and reinforces intergenerational cycles of poverty.
UNICEF also reminds that, worldwide, about 168 million children aged 5 to 17 are engaged in child labour, accounting for almost 11 per cent of all children.
The most recent figures, based on statistical evidence from UNICEF, ILO and the World Bank, show a decline of about one third since 2000.
While that is positive news, progress is far too slow, the UN specialised agency reports, adding that the continued persistence of child labour poses a threat not only to the health and well being of children, but also to national economies and the achievement of global development goals.
Child labour is defined as work for which the child is too young – i.e., work done below the required minimum age.
Other international instruments further define a child's right to be protected from the "worst forms of child labour," including recruitment in armed conflict, sexual exploitation and drug trafficking.
No one nation has so 170 mln. enslaved children. Children from 5 -16 years must have education reading, writing, calculating , working lessons, learning -at shools. Working age from 14- 16- until 60 years. after can be pension for citizens. Another way just crimes, fooling against children, no matter how named (modern slavery, traficing, human children bussines – stop these crimes and fooling) Make protection laws at each state.


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The purpose of our company is to deliver re-enactment services that range from displays at Medieval Fayres to the selling of Replica Artefacts. The mainstay of our company however is our collection of Historic Ship replicas which has been used successfully as a teaching medium in Schools, Museums and Libraries and as a visual back drop in all forms of Media work. We offer these services across a range of time lines from Ancient Greek to Victorians although we specialise in the Dark Age period of the Vikings!. The company was founded in 2000 and has had many complimentary reviews.
View our other links below.


i. Shared commitment to restructuring Nigeria to guaranty true federalism.
ii Need to promote the feelings of inclusiveness and sense of belonging amongst Nigerians and promote much desired national patriotism and unity.
4. The AFENIFERE hereby calls on Nigerians and all Yoruba people, in particular, to come out enmasse and vote for the candidacy of Alhaji Atiku Abubakar and Mr. Peter Obi of the Peoples Democratic Party and to protect their votes in the interest of good governance and life more abundant for all Nigerians.
4. Senator (Dr) Femi Okurounmi CON.


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Order of the Ministry of Healthcare of the Russian Federation No. 388 as of 01.11.2001 Order of the Ministry of Healthcare of the Russian Federation No. 388 as of 01.11.2001
The Order of the Ministry of Healthcare of the Russian Federation No. 388 as of 01.11.2001 "On State Quality Standards of Medicines" (registered with the Russian Ministry of Justice No. 3041 as of 16.11.2001) approved the Industry Standard 91500.05.001-00 "Quality Standards of Medicines. Basic Provisions", which regulates the procedures of development, execution, expert evaluation, agreement, approval, designation, and registration of state quality standards of medicines and the procedure of introduction of amendments to them.
The Industry Standard is given below.
Order of the Ministry of Healthcare of the Russian Federation No. 388 as of 01.11.2001
Содержимое (Table of Contents)
1 INDUSTRY STANDARD. QUALITY STANDARDS OF Medicines. BASIC PROVISIONS
1.1 General provisions
1.2 Terms and definitions
1.3 III. Preparation procedure for state quality standards of medicines
1.4 Procedure of arrangement and presentation of state quality standards of medicines
1.5 Procedure of submittal of state quality standards of medicines for expert evaluation, agreement, and approval
1.6 Procedure of designation and registration of state quality standards of medicines
1.7 VII. Procedure of introduction of amendments to state quality standards of medicines
1.8 Pharmaceutical forms. Terms and definitions
1.9 Principal groups of medical immunobiological medicines
1.10 List of sections in monographs and in-house monographs
1.10.1 Pharmaceutical substance
1.10.2 Pharmaceutical forms for injections
1.10.2.1 (solutions for injections)
1.10.2.2 Dry pharmaceutical forms for injections (powders for preparation of solutions and suspensions for injections)
1.10.3 III. Eye drops
1.10.4 Liquid pharmaceutical forms for oral and external use (solutions, suspensions, syrups, and emulsions)
1.10.5 Aerosols
1.10.6 Tablets and pills
1.10.7 Capsules (microcapsules)
1.10.8 Suppositories
1.10.9 Ointments (creams, gels, liniments, pastes)
1.10.10 Medicinal plant raw materials and mixtures (packaged products: cakes, bags, filter bags, cut and compressed form, etc.)
1.10.11 Tinctures and elixirs
1.10.12 Extracts (liquid, soft, dry)
1.10.13 Homeopathic products
1.10.13.1 Pharmaceutical forms for injections
1.10.13.2 Liquid pharmaceutical forms for oral and external use
1.10.13.3 Suppositories
1.10.13.4 Ointments
1.10.13.5 Tablets and pills
1.10.13.6 Granules (grains)
1.10.14 XIV. Immunobiological medicines (allergens, allergoids, anatoxins, bacteriophages, vaccines, immunoglobulins (antibodies), Immunomodulators, and diagnostic products)
1.10.14.1 Vaccines and anatoxins
1.10.14.2 Human immunoglobulins
1.10.14.3 Heterologous serums
1.10.14.4 Bacteriophages
1.10.14.5 Immunomodulators
1.10.14.6 Allergens and allergoids
1.10.14.7 Probiotics
1.10.14.8 Diagnostic products
1.10.14.9 Immunoenzyme and polymerase chain reaction-based test-systems
1.10.14.10 Bacteriological nutrient media
1.10.14.11 Nutrient media, solutions, and growth factors for cell cultivation
1.10.15 Human blood products
1.10.15.1 Liquid pharmaceutical forms of blood products
1.10.15.2 Dry and frozen pharmaceutical forms of blood products
1.11 Arrangement and presentation of state quality standards of medicines for substances
1.12 Arrangement, contents, and presentation of state quality standards for medicinal products
1.13 Arrangement, contents, and presentation of state quality standards for medicinal plant raw materials
1.13.1 Share this:
INDUSTRY STANDARD. QUALITY STANDARDS OF Medicines. BASIC PROVISIONS
OST 91500.05.001-00
1.1. The Industry Standard 91500.05.001-00 "Quality Standards of Medicines. Basic Provisions" (hereinafter the "OST") was developed in accordance with the Law of the Russian Federation No. 5154-1 as of 10.06.93 "On Standardization", Federal Law No. 86-FZ as of 22.06.98 "On Medicines", and Statute of the Ministry of Healthcare of the Russian Federation, approved by the Decree of the Government of the Russian Federation No. 659 as of 03.06.97 (amended and revised).
1.2. This OST establishes the procedures of development, execution, expert evaluation, agreement, approval, designation, registration of, and introduction of amendments to state quality standards of medicines.
1.3. This OST does not apply to:
— blood and its components used in transfusiology;
— raw materials of animal origin used exclusively for preparation of products subject to further processing for preparation of medicines;
— medicines made in pharmacy institutions.
The following terms with the corresponding definitions are used for the purpose of this OST:
excipients: substances of organic or inorganic nature that are used in manufacture of finished pharmaceutical forms to impart the desired properties to them. The list of excipients is extensive; depending on the type of pharmaceutical form, they may include thickening agents, surface and buffer, corrigents, preservatives, stabilizers, fillers, leavening agents, glidants, etc.;
homeopathic medicines: single- or multicomponent products that normally contain microdoses of active compounds, manufactured through a special procedure and intended for oral, injection, or topical administration in various pharmaceutical forms;
state reference standard: a reference standard, the quality parameters of which are regulated by the duly approved monograph. Working reference standards of medicinal substances can be used in analysis of finished pharmaceutical forms;
state pharmacopoeia: a collection of monographs*;
making of medicines: making of medicines in a pharmacy institution that holds a license for pharmaceutical activity according to the rules of making medicines approved by the federal authority for quality control of medicines;
immunobiological medicines: medicines intended for immunologic prophylaxis and immunologic therapy*;
blood components: blood cells, corpuscles, and plasma, obtained from blood and intended for administration to a recipient;
blood: a liquid obtained from a human donor, which consists of cellular elements and plasma and is used after a due inspection for obtaining separate components and administration to a recipient.
medicines: substances used for prevention, diagnostics, and treatment of diseases and pregnancy prevention, obtained from blood and plasma, as well as organs and tissues of humans or animals, plants, minerals, via synthesis or with the aid of biological technologies. Medicines also include substances of plant, animal, or synthetic origin that exhibit pharmacological activity and are intended for manufacture and making of medicines*;
medicinal products: dosed medicines in a specific pharmaceutical form;
pharmaceutical form: a state, convenient for usage, imparted to a medicine or medicinal plant raw materials for achieving the desired therapeutic effect (the definitions of pharmaceutical forms that can be used in preparation of state quality standards of medicines are given in Annex 1 to this OST);
international nonproprietary name (INN): name of a medicine approved by the World Health Organization (WHO);
circulation of medicines: a general concept of activities that include development, studies, manufacture, making of, storage, packaging, transportation, state registration, standardization and quality control, selling, labeling, advertising, use of medicines, disposal of medicines that became unfit for use or medicines past their expiry date, and other activities in the sphere of circulation of medicines*;
developer of a medicine: an organization that holds patent rights to a medicine and the copyright on the results of its preclinical studies*;
manufacturer of medicines: an organization that manufactures medicines in accordance with the requirements of this Federal Law*;
blood products: medicinal products obtained from human blood and released in liquid, dry, and frozen form;
proprietary medicines: medicines, rights to manufacture and selling of which are protected by the patent legislation of the Russian Federation*;
working reference standard: a sample of a batch substance that meets the requirements of the corresponding quality standard of medicines;
batch: a certain amount of a medicine obtained as a result of one manufacturing cycle. The main requirement to a batch is its uniformity.
reference standards: substances used for quality control of medicines that are compared against the tested medicines in analyzing the latter through physicochemical and biological methods. Reference standards are divided into chemical and biological for convenience; one and the same reference standard can be used for physicochemical as well as biological analyses in accordance with the directions of a monograph;
shelf life: a period of time, within which a medicine should fully satisfy all the requirements of the corresponding state quality standard of a medicine;
substance: a substance of plant, animal, microbial, or synthetic origin that exhibits pharmacological activity and is intended for manufacture and making of medicines;
monograph: a state quality standard of a medicine that contains the list of quality tests and control methods for a medicine*.
III. Preparation procedure for state quality standards of medicines
3.1. The following types of state quality standards of medicines are developed and approved:
1) general monograph (OFS);
2) monograph (FS);
3) in-house monograph (FSP).
3.2. State quality standards of medicines should ensure the development of a quality, effective, and safe medicine.
3.3. State quality standards of medicines should be revised in a timely manner considering the recent medical, pharmaceutical, and other scientific achievements, provisions of the leading foreign pharmacopoeias, and recommendations of the leading international organizations in the sphere of pharmaceutics.
3.4. A general monograph includes the list of tests or testing methods for a specific pharmaceutical form, description of physical, physicochemical, chemical, biochemical, biological, and microbiological methods of analysis of medicines, and requirements to reagents, titrated solutions, and indicators used.
3.5. A monograph is developed for a medicine under an international nonproprietary name if available (for monocomponent medicines) and contains the list of mandatory tests and quality control methods (considering its pharmaceutical form), corresponding to the provisions of the leading foreign pharmacopoeias.
3.6. The development of a monograph for an original (proprietary) medicine during the term of patent protection and its inclusion into the State Pharmacopoeia is only possible by agreement with the developer of a medicine or after the term of the patent has expired.
3.7. General monographs and monographs constitute the State Pharmacopoeia.
3.8. The State Pharmacopoeia is published by the Russian Health Ministry and is subject to republication every 5 years.
3.9. An in-house monograph contains the list of tests and quality control methods for a medicine, manufactured by a specific manufacturer and is developed in view of the requirements of the State Pharmacopoeia and this standard.
Quality requirements for medicines, contained in an FSP, should not be lower than the requirements stated in the State Pharmacopoeia, in view of the requirements of this standard.
3.10. The effective period of an FSP is established taking into account the level of manufacturing process of the specific manufacturer of a medicine, but must not exceed 5 years.
3.11. When developing a new medicine, an FSP for the substance used in its manufacture is developed simultaneously with an FSP for said medicine, in the case of absence of a state quality standard of a medicine for the substance.
When developing a new immunobiological medicine, an FSP for the substance used in its manufacture is developed if necessary.
3.12. General monographs and monographs for reference standards are developed by an organization authorized by the Russian Ministry of Health.
Procedure of arrangement and presentation of state quality standards of medicines
4.1. The title of a state quality standard of a medicine gives the name of the medicine.
4.2. The list of the principal sections of an FS and an FSP and the order of their presentation, considering specific pharmaceutical forms, is given in Annex 2 to this OST.
4.3. All quality tests contained in an FSP should be presented in form of a summary table (specification). The specification is a mandatory part of an FSP.
4.4. The order of arrangement of state quality standards of medicines for substances, medicines, and medicinal plant raw materials is given in Annexes 3-5 to this OST.
4.5. Title pages of an OFS, FS, or FSP should be arranged in accordance with Annexes 6, 7, and 8 to this OST.
The last page of an FSP should be arranged in accordance with Annex 9 to this OST.
4.6. Sections of an OFS, FS, or FSP are not numbered.
4.7. The presentation of the text should be concise, contain no repetitions, and exclude the possibility of different interpretations.
4.8. The abbreviation of words in the text and inscriptions under figures, schemes, and other illustrations is not permitted, excluding abbreviations used in the legislation of the Russian Federation.
4.9. Quality requirements to medicines in the text part of standards are presented in form of imperative.
When presenting the mandatory requirements, limits, and methods, such words as "shall", "should", "required" and their derivatives are used.
4.10. Section titles start a new paragraph and are set off in boldface font or underlined.
4.11. If the requirements, limits, methods, etc. applying to a medicine are established in the State Pharmacopoeia or other state or industry standard, references to the sources should be given instead of repeating their text.
4.12. The presentation of the text on the substance used in manufacture of a medicine should be accompanied by a reference to the regulatory document, according to which it is manufactured.
4.13. If the text of an OFS, FS, or FSP contains references to reagents, auxiliary materials, etc. that are manufactured in accordance with other regulatory documents, the designation of such documents should be given.
Procedure of submittal of state quality standards of medicines for expert evaluation, agreement, and approval
5.1. A draft state quality standard of a medicine, signed by its Developer, is submitted together with the following documents:
— cover letter;
— explanatory note;
— tabulated analytical data confirming the numeric values given in the draft state quality standard of a medicine for at least 5 batches of samples (3 batches of samples for immunobiological medicines);
— tabulated analytical data confirming the shelf life of the product, in accordance with the requirements of the corresponding industry standard;
— draft instruction for use of a medicine (for a new medicine or a generic medicine, for which a state quality standard of a medicine is developed for the first time);
— tabulated comparison of tests provided by the draft state quality standard of a medicine against the same tests given in national and foreign pharmacopoeias if available;
— product sample in a labeled package;
— certificate of metrological guarantee of quality control of a medicine.
5.2. An explanatory note to the draft state quality standard of a medicine should contain the following information:
— name of Manufacturer (Developer) of the medicine;
— brief description of synthesis or manufacturing procedure of the product;
— detailed justification of the investigation methods, tests, and limits, given in the draft, and also the description of other methods that were used to analyze the given medicine or substance;
— number of samples and manufacturing documents used in development of the draft state quality standard of a medicine;
— detailed justification of deviations from the general requirements of the State Pharmacopoeia, if any;
— foreign pharmacopoeias and other sources that describe a similar medicine with the data on the quality compared to foreign medicines; if a medicine is new or original, this fact should be mentioned.
5.3. An explanatory notes and tabulated analysis results are signed by the Manager of the Manufacturer (Developer) of the medicine or by a person authorized by them.
5.4. An expert evaluation of the draft quality standard of medicines and its agreement are performed by organizations authorized by the Russian Ministry of Health.
If necessary, the Russian Ministry of Health can involve core organizations into experimental testing of the state quality standard of a medicine by agreement with the Manufacturer.
5.5. An expert evaluation investigates the scientific and technical level of the draft state quality standard of a medicine and its compliance with the current requirements to regulatory documents for medicines, including the following:
— correspondence of quality tests and limits of a medicine and its consumer package to the requirements of the State Pharmacopoeia;
— justification of the list of tests and optimality of quality limits and shelf life of a medicine;
— accuracy and unambiguousness of the terms, definitions, chemical nomenclature, and physical units used.
5.6. Individuals involved into the expert evaluation and approval of in-house monographs should ensure confidentiality of the information obtained through this work.
5.7. The organization, authorized by the Russian Ministry of Health for conducting the expert evaluation of a state quality standard of a medicine, sends the documents to the Russian Ministry of Health for approval following the expert evaluation.
Procedure of designation and registration of state quality standards of medicines
6.1. Following the approval, an OFS, FS, or FSP is registered with the organization authorized by the Russian Ministry of Health and designated.
6.2. A designation of an OFS and FS should consist of an abbreviated name of the type of state quality standard of a medicine, code of the Russian Ministry of Health, registration number assigned to the document, and the last two digits of the year of approval or revision, separated by dashes.
Example: OFS or FS 42-00001-00, where
OFS or FS: abbreviated name of the category of quality standard of a medicine;
42: code assigned to the Russian Ministry of Health for designation of documents on standardization;
00001: registration number of the document;
00: last two digits of the year of approval of the document (00 for 2000, 01 for 2001, 02 for 2002, etc.).
6.3. A designation of an FSP should consist of the abbreviated name of the type of state quality standard of a medicine, code of the Russian Ministry of Health, code of the enterprise, registration number of the document, and the last two digits of the year of approval of the standard, separated by dashes.
Example: FSP 42-0001-00001-00, where
FSP: abbreviated name of the type of state quality standard of a medicine;
0001: four-digit code of the enterprise;
00: last two digits of the year of approval of the document.
6.4. Registration numbers are assigned sequentially starting from 00001.
6.5. Codes of enterprises are made up from four digits starting from 0001.
A code of enterprise is assigned to the Manufacturer or the Developer of medicines upon submittal the first FSP for approval.
VII. Procedure of introduction of amendments to state quality standards of medicines
7.1. Amendments are introduced into state quality standards of medicines when the higher scientific and technological level makes it possible to improve the quality of a medicine or to make the quality tests more precise. The amendments introduced must not result in the quality degradation of medicines.
7.2. The first page of an amendment to a quality standard of a medicine is executed in the form given in Annex 10.
7.3. Texts of the old and the new versions of sections (subsections or paragraphs) are given in full.
The expert evaluation and approval of the amendments introduced into state quality standards of medicines are performed according to the procedure established for the expert evaluation and approval of state quality standards of medicines.
* Article 4 of the Federal Law "On Medicines"
Annex 1
to the Industry Standard OST 91500.05.001-00 "Quality Standards of Medicines. Basic Provisions"
Pharmaceutical forms. Terms and definitions
Aerosols: a pharmaceutical form that is presented as solutions, emulsions, and suspensions of pharmaceutical substances, pressurized with propellants in a tightly sealed container equipped with a spray valve (metering or non-metering).
An aerosol where the contents of a container are released with the help of air is called a spray.
Aerosols are intended for inhalation. A type of inhalation is powders for inhalation (inhalers) that can be supplied in special metering devices such as rotadisks, ventodisks, etc.
Aerosols may also be intended for application of a medication on the skin, mucous membranes, and wounds.
Cakes: solid single-dose pharmaceutical form obtained through pressing of comminuted medicinal plant raw materials or a mixture of various types of plant raw materials without excipients, intended for the preparation of infusions and decoctions.
Granules: solid single-dose or multi-dose pharmaceutical form for oral administration consisting of spherical or irregular aggregates (grains) that contain a mixture of active ingredients and excipients.
Granules may be coated, including gastro-resistant; uncoated; effervescent; for the preparation of oral solutions and with modified release of active ingredients. A multi-dose package with granules may be equipped with a metering device.
Pills: solid single-dose pharmaceutical form obtained through layering active ingredients on microparticles of inert carriers with the aid of sugar syrups.
Drops: liquid pharmaceutical form containing one or more active ingredients, dissolved, suspended, or emulsified in a suitable solvent and metered in drops.
Two types of drops may be distinguished: for oral use and for external use.
Capsules: single-dose pharmaceutical form, which consists of a hard or soft gelatin shell containing one or more active ingredients with or without excipients.
Capsules can be divided into: hard, soft, microcapsules, gastro-resistant, and pellets.
gastro-resistant: capsules that release their active ingredient in the intestinal fluid.
microcapsules: capsules that consist of a thin shell, made of polymer or other material, are spherical or irregular in shape and 1 to 2,000 µm in size, and contain solid or liquid active ingredients with or without excipients.
soft: single-part capsules of various shapes (spherical, oviform, oblong, etc.) with liquid or paste-like substances.
hard: cylindrical capsules with hemispherical ends that consist of two parts inserted one into the other without gaps. Capsules may be filled with powders, granules, microcapsules, pellets, and tablets.
Pellets: coated solid spherical particles that contain one or more active ingredients with or without excipients and are 2,000 to 5,000 µm in size.
Pharmaceutical forms for injections: sterile pharmaceutical forms for parenteral use presented as solutions, suspensions, and emulsions, and also as solid pharmaceutical substances (powders, tablets, porous masses) that are dissolved in a sterile solvent immediately before administration. Injections may be of small volume (up to 100 ml) and of large volume (100 ml and more) (infusions).
powders for injections: sterile solid medicines used for the preparation of solutions or suspensions for injections.
solutions for injections: sterile aqueous or non-aqueous solutions of pharmaceutical substances in a suitable solvent.
suspensions for injections: sterile finely dispersed suspensions.
emulsions for injections: sterile finely dispersed emulsions.
Ointments: soft pharmaceutical form intended for application on the skin, mucous membranes, and wounds, which consists of a basis and pharmaceutical substances homogeneously dispersed in it.
By the type of disperse system, ointments can be divided into: homogeneous (alloys and solutions), suspension, emulsion, and combination; depending on their consistency: ointments proper, creams, gels, liniments, and pastes.
gels: viscous ointments that are able to hold their shape and are elastic and plastic.
By the type of disperse system, hydrophilic and hydrophobic gels are distinguished.
creams: soft ointments that are oil-in-water or water-in-oil emulsions.
liniments: ointments presented as viscous liquids.
pastes: thick ointments with the content of powder-like substances exceeding 25%.
Tinctures: liquid pharmaceutical form presented as alcoholic and aqueous-alcoholic extractions from medicinal plant raw materials, obtained without heating and removal of the extract.
Solutions: liquid pharmaceutical form obtained by dissolving liquid, solid, or gaseous substances in a suitable solvent.
Solutions are used orally and externally, and also for injections.
Medicinal plant mixtures: mixtures of several types of comminuted (rarely whole) medicinal plant raw materials, sometimes with the addition of salts and essential oils.
Syrups: liquid pharmaceutical form for oral use presented as a concentrated solution of various sugars, and also their mixture with pharmaceutical substances.
Suppositories: solid single-dose pharmaceutical form that consists of a basis and pharmaceutical substances and melts (dissolves, disintegrates) at body temperature.
Suppositories are intended for rectal (suppositories), vaginal (pessaries and balls) and other routes of administration (sticks).
Suspensions: liquid pharmaceutical form that is a disperse system containing one or more solid pharmaceutical substances suspended in a suitable liquid.
Suspensions are used orally and externally, and also for injections.
Tablets: solid single-dose pharmaceutical form obtained by compressing powders and granules that contain one or more pharmaceutical substances with or without excipients.
Tablets can be divided into: uncoated, effervescent, coated, gastro-resistant, modified-release, and for use in the mouth.
gastro-resistant: tablets that resist the gastric fluid and release their pharmaceutical substance or substances in the intestinal fluid.
They are prepared by covering tablets with a gastro-resistant coating (enteric-coated tablets), or by compressing granules and particles already covered with gastro-resistant coating, or by compressing pharmaceutical substances together with a gastro-resistant filler (durules).
uncoated: single-layer or multi-layer tablets obtained by single or successive compression. In multi-layer tablets, each layer may contain different pharmaceutical substances.
coated: tablets covered with one or more layers of various substances, such as natural and synthetic materials and carbohydrates, with the possible addition of surfactants. Thin coating (less than 10% of a tablet mass) is usually called film coating.
Sugar coating, which contains one or more pharmaceutical substances and is layered on microparticles of inert carriers, makes it possible to prepare a pharmaceutical form called pills.
effervescent: uncoated tablets usually containing acid substances and carbonates or hydrogen carbonates, which react rapidly in the presence of water to release carbon dioxide; they are intended to be dissolved or dispersed in water immediately before administration.
for use in the mouth: usually uncoated tablets prepared by a special procedure to effect a release of a pharmaceutical substance or substances in the oral cavity for topical or systemic absorption (buccal tablets, sublingual tablets, etc.).
modified-release: coated or uncoated tablets that contain special excipients or are prepared by special procedures, designed to modify the rate and the place at which pharmaceutical substance is released.
Extracts: concentrated extractions from medicinal plant or animal raw materials presented as mobile, viscous liquids or dry masses. Extracts are divided into: liquid extracts (mobile liquids); soft extracts (viscous masses with the moisture content not more than 25%); dry extracts (loose masses with the moisture content not more than 5%).
Elixirs: liquid pharmaceutical form presented as a clear mixture of aqueous-alcoholic extractions from medicinal plant raw materials with the addition of pharmaceutical substances, sugars, and flavoring agents.
Emulsions: liquid pharmaceutical form that is a disperse system containing two or more mutually insoluble or immiscible liquids, one of which is emulsified in the other.
Emulsions are used orally and externally, and also for injections.
Principal groups of medical immunobiological medicines
Allergens and allergoids: substances of antigenic or haptenic nature used for hyposensibilization and allergy diagnostics.
Anatoxins: bacterial exotoxins that have lost their toxicity as a result of inactivation (e.g. with formalin), but retain their antigenic properties.
Bacteriophages: viruses capable of penetrating into a bacterial cell, replicating within it, causing its lysis or transition to lysogeny (phage carriage).
Vaccines: medicines obtained from live attenuated strains or killed microbial cultures or their antigens and intended for active immunization.
Diagnostic immunobiological medicines: medicines intended for diagnostics of infectious diseases.
Immunoglobulins (antibodies): immunologically active protein fraction of human or animal blood serum (plasma) that contains antimicrobial and/or antitoxic antibodies.
Immunomodulators: substances that modify an immune response of the body, including cytokines, interferons, etc.
Probiotics: bacteria that are apathogenic for humans and exhibit antagonistic activity against pathogenic and opportunistic bacteria, facilitating the restoration of normal microflora.
Heterologous serums: blood serums obtained from the animals immunized with this or that antigen that contain corresponding antibodies.
List of sections in monographs and in-house monographs
Pharmaceutical substance
Product name in Russian
International nonproprietary name (INN) in Russian
Chemical name in accordance with the IUPAC requirements
Structural and empirical formulae and molecular mass
Content of the active ingredient (in percent or units)
Melting (decomposition) point, or freezing point, or boiling point
Specific absorbance
Clarity of solution
Colority of solution
рН, or acidity, or alkalinity
Particulate contamination
Impurities (related substances)
Purity tests (chlorides, sulfates, sulfated ash, heavy metals, etc.)
Loss on drying, or water via Karl Fischer titration
Residual solvents (if used at the final stage of the manufacturing process)
Pyrogens, or bacterial endotoxins (LAL test)
Histamine-like substances
Microbiological purity, or sterility
Pharmacological group
Note. Sections 1, 3-8, 18, 20, 25-32 are mandatory.
The inclusion of other sections depends on the nature of the pharmaceutical substance, manufacturing procedures, and pharmaceutical forms that will be prepared from this substance.
Pharmaceutical forms for injections
(solutions for injections)
INN in Russian
Colority
Nominal volume
Note. Sections 1-6, 9, 13, 17-24 are mandatory.
The inclusion of other sections depends on the nature of the pharmaceutical substance, preparation procedure of the given pharmaceutical form, and method of its administration.
Dry pharmaceutical forms for injections (powders for preparation of solutions and suspensions for injections)
Average mass and uniformity of mass
Loss on drying, or water
Uniformity of dosage units
Note. Sections 1-7, 10, 18-24 are mandatory.
The inclusion of other sections depends on the nature of the pharmaceutical substance, preparation procedure of the given pharmaceutical form, and method of its administration. If necessary, the section "Solubility", which specifies the time of complete dissolution when preparing a solution in accordance with the instruction for use, can be included as well.
III. Eye drops
Osmolality
Note. Sections 1-6, 8-11, 14-21 are mandatory.
The inclusion of other sections depends on the nature of the pharmaceutical substance.
Liquid pharmaceutical forms for oral and external use (solutions, suspensions, syrups, and emulsions)
Microbiological purity
Note. Sections 1-5, 10-18 are mandatory.
INN (for monocomponent medicines) in Russian
Leakage test
Valve function test
Dosage unit mass
Number of discharges per container
Delivered amount
Note. Sections 1-8, 11, 15, 17-23 are mandatory.
The inclusion of other sections depends on the nature of the pharmaceutical substance and dosage.
Tablets and pills
Talc, aerosil, titanium dioxide
Dissolution, or disintegration
The inclusion of other sections depends on the nature of the pharmaceutical substance and dosage. The test "Uniformity of mass" is not performed if the test "Uniformity of dosage units" is included.
Capsules (microcapsules)
Average mass of the contents and uniformity of mass
Note. Sections 1-7, 9, 11-17 are mandatory.
Melting point, or softening time, or time of dissolution
Note. Sections 1-7, 9-16 are mandatory.
The inclusion of other sections depends on the nature of the pharmaceutical substance and dosage. The test "Uniformity of mass" is not performed if the test "Uniformity of dosage units" is included
Ointments (creams, gels, liniments, pastes)
Mass of the contents of a container
pH of an aqueous solution
Medicinal plant raw materials and mixtures (packaged products: cakes, bags, filter bags, cut and compressed form, etc.)
Product name in Russian and Latin.
Latin and Russian names of the producing plant(s) and their families.
Identification test for whole and comminuted raw materials:
3.1. Appearance;
3.2. Microscopy illustrated with a microphotograph or a drawing;
3.3. Qualitative and/or histochemical reactions; chromatographic tests.
Quantitative tests for whole and comminuted raw materials:
4.1. Content of pharmacologically active substances or biological activity;
4.2. Loss on drying;
4.3. Total ash;
4.4. Ash insoluble in 10% hydrochloric acid solution;
4.5. Impurities: comminuted (sieve test), discolored pieces of the raw materials, other parts of the plant not subject to harvesting, organic impurity, mineral impurity.
Microbiological purity.
Packaging of whole and comminuted raw materials (bulk) and packaged products (packs, bags, cakes, cut and compressed form, filter bags, etc.).
Labeling of whole and comminuted raw materials and packaged products (packs, bags, cakes, cut and compressed form, filter bags, etc.). Additional indication: "The product has passed the radiological control according to SanPiN 2.3.2560-96"
Pharmacological group.
Note. The quality evaluation of packaged products in cakes and cut and compressed form includes the additional disintegration and uniformity of mass tests.
Tinctures and elixirs
Alcohol content, or density
Dry residue
Packaging, labeling, storage
Extracts (liquid, soft, dry)
Alcohol content, or density (for liquid extracts)
Loss on drying (for soft and dry extracts)
Average mass (for single-dose extracts)
Granulometric composition (for dry extracts)
Composition with the indication of homeopathic dilutions of the components and their amounts, as well as all excipients and preservatives
Identification test
Colority (evaluation method and standard)
Clarity (evaluation method and standard)
Particle size (for suspensions and emulsions)
Solution рН
Nominal volume determination
Particulate contamination test
Pyrogen test (test dose) (if necessary)
Pharmacological activity (for complex products only)
Liquid pharmaceutical forms for oral and external use
Description (appearance, color)
рН (if necessary)
Alcohol content (for alcohol-containing products)
Composition per suppository with the indication of homeopathic dilutions of the components and their amounts, as well as all excipients
Average mass of a suppository, variation limits
Homogeneity test
Composition with the indication of homeopathic dilutions of the components and their amounts, as well as all excipients
рН of an aqueous solution (if necessary)
Homogeneity test, or particle size
Composition per tablet with the indication of homeopathic dilutions of the components and their amounts, as well as all excipients and fillers
Average mass of tablets, and mass variation
Granules (grains)
Composition per granule with the indication of homeopathic dilutions of the components and their amounts, as well as all excipients
Number of pieces in 2 g
Mass of the contents of a container and mass variation
Note. The necessity of introducing the sections "Identification" and "Assay" for homeopathic products is determined individually depending on the composition of the product and the limit of detection of its components
XIV. Immunobiological medicines (allergens, allergoids, anatoxins, bacteriophages, vaccines, immunoglobulins (antibodies), Immunomodulators, and diagnostic products)
Vaccines and anatoxins
Introductory part
Solubility (for dry products); disintegration (for tablets)
Absence of particulate contamination (for products administered parenterally)
9.<* >Loss on drying
Vacuum (shielding gas, hermetization)
11.<*>Chemical tests (protein; total protein nitrogen; nucleic acids; polysaccharides, etc.)
Sterility (absence of foreign microorganisms and fungi for live vaccines)
Microbiological purity (for non-injection forms)
14.<*>Pyrogens or bacterial endotoxins
16.<*>Specific safety
Specific activity (immunogenicity)
18.<*>Antigenic activity
Completeness of absorption (for absorbed products)
20.<*>Thermostability
Master strains
24.<*>Antibiotic content
Solvents included with the product
Packaging, labeling, transportation, storage
Human immunoglobulins
Solubility (for dry products)
Absence of particulate contamination
Electrophoretic homogeneity
Molecular parameters
Fractional composition
Thermostability (for liquid products)
Pyrogens, or bacterial endotoxins
Specific activity (for specific antiviral, antibacterial, or antitoxic Ig: antibody content expressed in IU, titers, etc.; for products enriched with immunoglobulins of A or M classes: their quantitative content; for antiallergic products: antiallergic activity, etc. depending on the product)
Specific safety:
HBsAg and antibodies to HIV-1 and HIV-2 absence tests (other human blood contaminants in case of determined necessity) (all products);
anticomplementarity (for Ig intended for intravenous administration);
hypotensive activity (for histaglobulin, histaserotoglobulin, etc.).
Heterologous serums
4.<*>Solubility (for dry products)
Loss on drying (for dry products)
Vacuum (hermetization)
Pyrogens or bacterial endotoxins
Specific activity
18.<*>Solvents included with the product
Average mass (for tablets and suppositories)
Disintegration (for tablets). Dissolution (for suppositories)
Sterility, or microbiological purity (for tablets, suppositories, and ointments)
Immunomodulators
Chemical tests (protein; total and protein nitrogen; nucleic acids; polysaccharides, etc.)
Pyrogens
13.<*>Bacterial endotoxins
16.<*> HBsAg and antibodies to HIV-1 and HIV-2 absence tests (other human blood contaminants in case of determined necessity)
Allergens and allergoids
Protein nitrogen
Solvents and reagents included with the product
Dissolution (disintegration)
Average mass (for tablets, suppositories, and capsules)
6.<*>рН
8.<*>Vacuum (shielding gas, hermetization)
Absence of foreign microorganisms and fungi, or microbiological purity
Sterility, or microbiological purity
Immunoenzyme and polymerase chain reaction-based test-systems
4.<*>Solubility
7.<*>Loss on drying
8.<*>Sterility, or microbiological purity
Bacteriological nutrient media
Solution рН (extract pH for agar-containing media)
8.<*>Total nitrogen
Amine nitrogen
11.<*>Carbohydrates
Gel strength (for solid media)
Specific activity (medium sensitivity, growth rate and stability of the principal biological properties of microorganisms, and inhibitory and differentiative properties, the set of which and the procedures used depend on the intended use of a medium)
Nutrient media, solutions, and growth factors for cell cultivation
Loss on drying (для сухих препаратов)
8.<*>Chloride ion
9.<*>Glucose
10.<*>Amine nitrogen
11.<*>Protein
12.<*>Buffer capacity
13.<*>Osmosity
14.<*> Osmolarity
16.<*>Toxicity
<*>Impurities
Human blood products
Liquid pharmaceutical forms of blood products
Content of the active component in % or specific activity units
Identification, including the verification of homology with human blood proteins
Assay of the principal protein component
Fractional protein composition
Molecular parameters of the principal protein component
Hemagglutinins (anti-A and anti-B)
Thrombogenicity (for coagulolytic products)
Prekallikrein activator
Anticomplementary activity
Thermostability
Electrolytes (sodium, potassium, citrate, calcium, aluminum, etc.)
Bacterial endotoxins
Content of hemolytic substances
Test for the absence of antigens (antibodies) to hepatitis and human immunodeficiency viruses and other possible human blood contaminants
Dry and frozen pharmaceutical forms of blood products
Content of the active component in mg specific activity units
Characteristics of the included solvent, activator, or plasticizer
Description of the finished pharmaceutical form, and also following its dissolution (unfreezing)
Solubility, or time of dissolution in the included solvent (for dry products)
Colority (hem pigments)
Arrangement and presentation of state quality standards of medicines for substances
Name of the substance in Russian, international nonproprietary name (INN), and chemical name in accordance with the rules of the International Union of Pure and Applied Chemistry (IUPAC) are stated in the following order:
— Russian name;
— international nonproprietary name;
— chemical name.
In the middle under the name, the structural formula represented in accordance with the IUPAC's rules should be given.
In the empirical formula, which is given on the left under the structural formula, carbon comes first, hydrogen comes second, and the following elements including metals are stated in the alphabetical order, e.g.: С12H17CIN4OS * HCI.
The relative molecular mass should be given in accordance with the latest international atomic masses and specified to the second decimal place for relative molecular masses not exceeding 400, and to the first decimal place for relative molecular masses exceeding 400. The content of the main active ingredient is given in percent or units of activity.
Depending on the contents, the text of a quality standard for a substance should be divided into sections and have an introductory part, if necessary. The list of sections and their contents should be determined in accordance with the peculiarities of physicochemical properties and the nature of a medicine.
Some sections can be combined; other sections can be introduced, if necessary (preparation, creation of the calibration curve, preparation of the standard solution, etc.).
Measurement (control) methods should be presented in the third person plural. The section "Description" is presented in form of a narration.
The section "Description" establishes the appearance tests for a medicine (physical state, color, and odor), possible changes when storing it in the open air or under light (indication of hygroscopicity and effects of the air and light exposure). Odor is not indicated for poisonous and potent medicines.
The section "Identification" specifies the characteristics of the ultraviolet (UV) and infrared (IR) absorption spectra, etc. and 2-3 reactions that are the most characteristic of this product, if necessary.
The section "Solubility" specifies the solubility tests with water, 95% alcohol, chloroform, and ether (if a substance is practically insoluble in ether, ether is excluded from the list of solvents). Other solvents are stated if necessary. The descriptive terms of solubility and their values are presented in accordance with the general chapter of the State Pharmacopoeia, "Solubility". In cases when the precise solubility of a medicine is determined, the ratio between the mass of the solute and the volume of the solvent is given.
Temperature ranges of distillation, melting, or freezing, as well as density, specific rotation, specific absorbance, refractive index, and other physical constants are presented as separate sections that specify the upper and lower limits of these quality tests.
The clarity and colority of solutions are specified for a certain concentration; for colored solution, the number of the colority standard and the letters of the scale are given or the corresponding characteristics of the absorption spectra of such solutions are specified.
When determining the acidity and alkalinity limits with the indicators, the solutions of acids or alkalis with the concentration 0.01 M to 0.1 M are used; pH is determined potentiometrically.
The section "Impurities (related substances)" specifies the procedure of identification and the limits for processing aids or substances formed during storage. When using chromatographic methods for this purpose, the type of sorbent, composition of the phases, amount of the test substance to be chromatographed, amount of the reference standard (tracking substance), run time, development reagent, and all other conditions determining the chromatographic process should be specified.
The section "Residual solvents" should specify the colority standards that set the limits for organic impurities, or other modern methods, e.g. chromatography. The control of residual solvents is included if toxic solvents are used in the preparation procedure of a medicine and also if organic solvents are used at the final stage of the manufacturing process of a medicine.
The sections "Chlorides", "Sulfates", etc. specify the limits for these impurities related to the manufacturing process.
The sections "Loss on drying" and "Water" specify the weighting of the product, the determination procedure for Karl Fischer titration endpoint, drying conditions, and the limits for loss on drying or water content.
The section "Sulfate ash and heavy metals" specifies the weighting of the product and the limits for sulfate ash and heavy metals.
The section "Arsenic" specifies the limits for arsenic or its absence.
The sections "Toxicity", "Pyrogens", and "Histamine-like substances" specify test doses, methods of administration, and period of observation for the medicines tested.
The section "Sterility" is introduced when it is impossible to sterilize the pharmaceutical form. The section "Microbiological purity" describes the method of detection of microorganisms and their limits.
The section "Assay" describes the assay method for the principal substance contained in the product. This section also specifies the percentage of the principal substance or its activity in the units of activity (units/mg) with reference to the active ingredient.
The section "Packaging" specifies the primary package (individual package: jars, ampoules, vials, bags, etc.), number of product units in the primary package (e.g. the number of tablets in a bottle), secondary (consumer) package and the number of primary packages in it, hermetization methods, etc. References to the corresponding regulatory documents should be given for bundles and shipping package. A package should guarantee the safety of the medicine over the shelf life established.
The section "Labeling" is presented in accordance with the requirements of the regulatory documents to the graphic design of medicines.
The section "Transportation" gives a reference to the current standard. If necessary, the requirements related to loading and unloading of the products and handling of the products after transportation (e.g. the necessity to leave the products at room temperature following the transportation at negative temperatures, etc.) are specified.
The section "Storage" should specify the storage conditions for the products that guarantee that their quality and marketable state will remain intact and, if necessary, the requirements to protection of the products from environmental exposure (moisture, sunlight, temperature) and the peculiarities of storage for medicines that are poisonous, potent, psychotropic, narcotic, or their precursors (according to the corresponding current lists including lists A and B).
The section "Shelf life" specifies the period of time, within which the medicine can be used.
The section "Pharmacological (biological) activity" specifies the pharmacological group of the product.
Paragraphs 23, 24, 25, and 27 are not included into monographs.
Arrangement, contents, and presentation of state quality standards for medicinal products
The title of a standard specifies the name of the medicinal product in Russian.
The first word in the name of a medicinal product should be the name of the active ingredient (in the nominative case) or its trade name (in the nominative case), followed by the name of the pharmaceutical form, dosage (concentration), and volume. Example: Analgin tablets 0.5 g or Analgin solution for injection 25%.
Some sections can be combined, or, if necessary, other sections can be included (acid value, saponification value, iodine value, ester value, toxicity, pyrogens, histamine-like substances, sterility, etc.).
A standard should have an introductory part. The introductory part specifies the chemical name of the active ingredient (for monocomponent products); Russian and Latin names of plant raw materials, producing plant and its family (for tinctures and extracts).
The description of the composition of a medicinal product should specify the quantitative content of active ingredients and the qualitative composition of excipients as a list with references to the corresponding regulatory documents that contain quality requirements to them.
The section "Description" establishes organoleptic characteristics of the appearance of a finished medicine (color and odor). Attributes such as azure, egg, etc. must not be used. The principal color is specified at the end of the attribute, e.g. greenish blue (blue color with a tinge of green).
The section "Disintegration" specifies the time of total disintegration of a tablet or a capsule in a liquid medium (under the conditions stated in the State Pharmacopoeia).
The section "Identification" is given fully as described under Paragraph 9 Annex 3 to this OST.
For complex products, the identified ingredient is given in brackets after the description of the required determination.
The sections "Clarity" and "Colority" establish the clarity (turbidity) and color of the medicinal product compared to a solvent or the corresponding standard.
The section "Acidity", "Alkalinity", or "pH" is given fully as described under Paragraph 13 Annex 3 to this OST.
The sections "Dry residue", "Alcohol content", "Boiling point", "Density", "Refractive index", "Angle of rotation", and "Viscosity" specify the upper and lower limits of these quality tests in the corresponding measurement units.
The section "Dissolution" establishes the amount of the active ingredient that should pass into a solution within a specific period of time under the given conditions.
The section "Assay" describes the assay method for the active ingredient contained in the medicinal product.
This section also specifies the percentage of the active ingredient or activity in units of activity or micrograms to milligrams with reference to the active ingredient (units/mg or µg/mg) in the medicinal product or its pharmaceutical forms.
The limits of the content of the active ingredient in grams per tablet with reference to the average mass of tablets are specified for tablets, in grams per suppository for suppositories, in grams per pill for pills, and in grams per ml for solutions for injections.
The section "Microbiological purity" is given as described under Paragraph 21 Annex 3 to this OST.
The sections "Packaging", "Labeling", "Transportation", and "Storage" are given as described under Paragraphs 23-25 to this OST.
The section "Shelf life" is given as described under Paragraph 27 Annex 3 to this OST.
The section "Pharmacological activity" is given as described under Paragraph 28 Annex 3 to this OST.
Paragraphs 6, 15, and 16 are included into monographs if necessary.
Arrangement, contents, and presentation of state quality standards for medicinal plant raw materials
The title of a standard specifies the name of the medicinal plant raw materials in Russian and in Latin.
Russian and Latin names of the medicinal plant raw materials are given in plural.
The first word in the name of medicinal plant raw materials should be their denomination (in the nominative case) or trade name (in the nominative case), followed by the pharmaceutical form (mixture, cake, etc.).
A standard should have an introductory part. The introductory part specifies: name and field of use of the medicinal plant raw materials, producing plant and its family (in Russian and Latin).
The section "Appearance" briefly describes the morphological characteristics of the whole and the comminuted raw materials.
The section "Microscopy" describes the diagnostic characters of the raw materials, illustrated with microphotographs or drawings.
The section "Qualitative reactions" describes the procedures of microchemical, histochemical, etc. reactions or chromatographic tests.
The section "Quantitative tests" establishes the limits of percentage of active ingredients (pharmacologically active substances) or biological activity, moisture limits (loss on drying), total ash and ash insoluble in 10% hydrochloric acid solution, impurities, and fragment size.
The section "Assay" describes the determination procedures for the content of the active ingredients.
The section "Pharmacological activity" is given as described under Paragraph 28 Annex 3 to this OST. 4.13. Section titles start a new paragraph and are set off in boldface font or underlined.
Paragraphs 10, 11, and 12 are included into monographs if necessary
* Here and elsewhere in the text: the section is introduced if necessary
Download in PDF ost-91500-05-001-00-prikaz-388-from-01-11-2011

redpajama_set_name: RedPajamaCommonCrawl


If you've ever had to give a presentation you know there's a lot of work to do beforehand. But one thing that will help you nail your performance is a handy controller like the Logitech Spotlight.
Spotlight works with Mac and Windows computers and can also connect to tablets and smartphones as well so you can control your presentation no matter which device you choose to present it.
Logitech's Spotlight works with your most popular presenting applications like Powerpoint, Keynote, PDF, Google Slide and Prezi.
The device is narrow and light and fits nicely in your hand. It is 13.1cm long, 2.8cm wide, 1.2cm thick and weighs just 49.2g.
There is easy access to the main forward button to advance your slides and a back button.
The top button allows users to magnify parts of the screen which is enabled when you download and install the Logitech Presentation app.
Instead of the old-fashioned laser pointer, the Logitech Spotlight lets you enlarge the portion of the screen you'd like to emphasise.
Users are able to customise the back button to suit your presentation.
You can set it to blank the screen, to create gesture controlled scrolling and to control the volume.
You can also play and pause videos using the Spotlight controller so you don't need to go near your computer or mobile device to hit the play button.
And if you like moving around when you speak, you've got a 30m range with the Logitech Spotlight.
We used the Logitech Spotlight recently when we did a presentation as a guest of the Sydney Rotary Club.
The device makes it easy to move through your presentation so you can focus on what you're saying rather than worrying about if the next slide is going to appear at the right time.
You can set a timer for your presentation with the Logitech Presentation application so you know exactly how long you've been speaking as well as set key timing intervals that will send a vibration to the remote itself.
It has a USB receiver if you'd like to plug that into your computer but it also has Bluetooth onboard so you can wirelessly connect to a laptop or mobile device.
The device can be charged through the USB-C port which is revealed behind the USB receiver that plugs into the base of the device.
A full charge of the Logitech Spotlight can last for up to three months.
But just connecting the USB-C charging cable for one minute will give you three hours of presenting time.
The Logitech Spotlight is available now in slate, gold and silver and is priced at $199.95.
If you need make a presentation you need the Logitech Spotlight by your side. It gives you complete control so all you need to do is crush it – the presentation that is!
PROS: Great design, magnification feature, timer settings, comfortable to hold. CONS: A little expensive. VERDICT: If you need make a presentation you need the Logitech Spotlight by your side. It gives you complete control so all you need to do is crush it – the presentation that is!


We aim to reward businesses that create safer, healthier workplaces in NSW. Incentives are available for employers to report incidents early, introduce safety initiatives and support injured workers returning to work.
We also offer discounts for businesses that pay their insurance premium in full, on or before the due date.
Under this scheme, if you employ an apprentice, you're entitled to a premium reduction based on the wages paid to your apprentice.
Have entered into a Training Services NSW approved contract with the apprentice. The apprentice must be identified in the training contract.
We will calculate the apprentice incentive amount based on details you provide in your wages declaration forms.
If one of your workers suffers a workplace injury, you can avoid paying a claims excess by notifying us within five calendar days of you becoming aware of the injury.
The excess amount is the first week of weekly compensation and is prescribed by SIRA in the Workers Compensation Market Practice and Premium Guidelines.
You are entitled to a discount on your premium if you pay your annual premium in full (on or before the due date).
The discount is offered to everyone with a premium of over $175, regardless of your entitlement to instalments. It is available only to policies that are for a 12 month-duration.
The discount is based on your initial premium payable and will not be adjusted as part of the hindsight premium calculation process, or if wages estimates are adjusted mid-term.
The discount rate is subject to change. For small employers, the current discount is 5%. For experience-rated employers the current discount is 3%.
If you are a small employer, you will get a 10 per cent Employer Safety Incentive premium discount at the beginning of each policy period to assist you to make your workplace safe.
If all your injured workers are returned to suitable work within four weeks of the date of injury, with no ongoing requirement for payment of weekly compensation, you can keep the 10 per cent discount when your hindsight premium is calculated.
If you are an experience-rated employer, you will receive a 10 per cent employer safety incentive premium discount at policy renewal.
This provides an opportunity for employers to invest the savings in workplace safety.
For claims made against a policy that commences or renews on or after 30 June 2015, a return to work incentive discount (5, 10 or 15 per cent) will be applied to the cost of each claim with a sustainable return to work outcome up to 52 weeks.
Higher discounts apply to faster return to sustainable work outcomes.
1.	All your injured workers return to suitable and sustainable work.
2.	They return between four and thirteen weeks from the date of injury.
3.	They have no ongoing requirement for payment of weekly compensation.
Experience-rated employers with no premium-impacting claims costs in the last 4 years, including the current period, can get a 5% discount on their average performance premium, i.e. (APP- Apprentice Incentive) x 5%.


text:
/* ----------------------------------------------------------------------------
 * This file was automatically generated by SWIG (http://www.swig.org).
 * Version 3.0.10
 *
 * Do not make changes to this file unless you know what you are doing--modify
 * the SWIG interface file instead.
 * ----------------------------------------------------------------------------- */

package com.badlogic.gdx.physics.bullet.dynamics;

import com.badlogic.gdx.physics.bullet.BulletBase;
import com.badlogic.gdx.physics.bullet.linearmath.*;
import com.badlogic.gdx.physics.bullet.collision.*;
import com.badlogic.gdx.math.Vector3;
import com.badlogic.gdx.math.Quaternion;
import com.badlogic.gdx.math.Matrix3;
import com.badlogic.gdx.math.Matrix4;

public class CustomActionInterface extends btActionInterface {
	private long swigCPtr;

	protected CustomActionInterface(final String className, long cPtr, boolean cMemoryOwn) {
		super(className, DynamicsJNI.CustomActionInterface_SWIGUpcast(cPtr), cMemoryOwn);
		swigCPtr = cPtr;
	}

	/** Construct a new CustomActionInterface, normally you should not need this constructor it's intended for low-level usage. */
	public CustomActionInterface(long cPtr, boolean cMemoryOwn) {
		this("CustomActionInterface", cPtr, cMemoryOwn);
		construct();
	}

	@Override
	protected void reset(long cPtr, boolean cMemoryOwn) {
		if (!destroyed)
			destroy();
		super.reset(DynamicsJNI.CustomActionInterface_SWIGUpcast(swigCPtr = cPtr), cMemoryOwn);
	}

	public static long getCPtr(CustomActionInterface obj) {
		return (obj == null) ? 0 : obj.swigCPtr;
	}

	@Override
	protected void finalize() throws Throwable {
		if (!destroyed)
			destroy();
		super.finalize();
	}

  @Override protected synchronized void delete() {
		if (swigCPtr != 0) {
			if (swigCMemOwn) {
				swigCMemOwn = false;
				DynamicsJNI.delete_CustomActionInterface(swigCPtr);
			}
			swigCPtr = 0;
		}
		super.delete();
	}

  protected void swigDirectorDisconnect() {
    swigCMemOwn = false;
    delete();
  }

  public void swigReleaseOwnership() {
    swigCMemOwn = false;
    DynamicsJNI.CustomActionInterface_change_ownership(this, swigCPtr, false);
  }

  public void swigTakeOwnership() {
    swigCMemOwn = true;
    DynamicsJNI.CustomActionInterface_change_ownership(this, swigCPtr, true);
  }

  public void updateAction(float timeStep) {
    DynamicsJNI.CustomActionInterface_updateAction(swigCPtr, this, timeStep);
  }

  public void debugDraw() {
    DynamicsJNI.CustomActionInterface_debugDraw(swigCPtr, this);
  }

  public CustomActionInterface() {
    this(DynamicsJNI.new_CustomActionInterface(), true);
    DynamicsJNI.CustomActionInterface_director_connect(this, swigCPtr, swigCMemOwn, true);
  }

}

redpajama_set_name: RedPajamaGithub


Spot it! is played with 55 circular cards, each decorated with eight symbols varying in size and orientation. There are more than 50 symbols in all, including random yet universal images of hearts, snowflakes, dragons, and lightning bolts, and even words such as Stop and OK. The aim of the game is to be the first to spot the one symbol in common between two or more cards. Don't be fooled! It's not as simple as it sounds. A match is easily hidden in the array, especially with the pressure of racing frantically against your opponents. The cards change with every match made, so you have to stay focused to keep up.


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Bharti Airtel has reportedly begun testing its VoLTE services and will enable them as early as next week. The feature will help India's largest telecom operator compete against its closest competitor Reliance Jio.
As it looks to take on Reliance Jio, country's top mobile operator Bharti Airtel, which is currently undergoing trials for voice over LTE (VoLTE) in some cities including Mumbai, plans to launch commercial services in the next quarter. Also, Airtel's 4G footprint will cover all the towns and cities by end of 2017 financial year. The company has already launched 4G services in all the 22 telecom circles but a few cities and towns in the circles are currently not getting the latest technology but the company is upgrading its network to cover most of the country by end of FY17.
Since the launch of Jio's VoLTE service in September last year, there have been several rumors about leading telecom operators Airtel and Vodafone India incorporating VoLTE support to their networks. With the launch, Bharti Airtel is set to become the first incumbent player to offer VoLTE services. Voice over LTE or VoLTE uses the same network as mobile data to enable high-definition calls.
The report adds that Airtel customers in Mumbai and Kolkata will receive text messages to activate VoLTE calling when the service becomes available. Airtel currently offers voice services over traditional circuit-switch technology on 3G or 2G network while data services are offered using 4G network. With the rollout of VoLTE services, Airtel will be able to free up its 3G and 2G airwaves. Airtel could even reform that bandwidth to offer 4G data services.
Post-Diwali, VoLTE services from Airtel will cover Tier-2/Tier3 cities, thereby covering the whole of India by April 1st, 2018.
Major telecom operators including Bharti Airtel, Vodafone, and Idea Cellular are engaged in a fierce price battle with reliance jio. Jio's 4G only network has managed to acquire over 130 million customers in just one year and the company recently introduced a 4G feature phone called the Jio Phone with bundled data and calling benefits. Bharti Airtel is said to introduce its own competitor to the Jio Phone, but it will first need to roll out VoLTE services.
Reliance Industries is set to ship its VoLTE featurephone, JioPhone, starting this month for a refundable three-year deposit of Rs 1,500. It got bookings for 6 million units in a day and a half when it took orders. Indian phone makers such as Intex and Lava are also expected to launch similar models, thus creating a critical mass of low-cost VoLTE-ready phones. Airtel could benefit from the creation of a large ecosystem of VoLTE-based devices.
With the launch of VoLTE services. Airtel will be better equipped to tackle Jio, which has been touting the service as one of its major differentiators.
Sulekha Customer Care Toll Free Helpline Number and Office Address.


This essay collection, published in collaboration with Bright Blue and kindly sponsored by the City of London, considers London's future. It brings together a diverse group of influential, experienced and talented Londoners who outline an original action plan and vision for London in 2050 across a range of fields – from education and the environment to culture and commerce.
Gerard Grech, Chief Executive Officer of Tech City UK – A technological revolution?
Professor Tony Travers, Director of LSE London – London the city state?
Matthew Taylor, Chief Executive of the Royal Society of Arts – A city of communities?
Gavin Kelly, Chief Executive of the Resolution Trust – A view from 2050: did London share the wealth?
Professor Tony Travers and Michael Liebreich's essays were featured in City AM and the Telegraph respectively.


text:
Moody's Cuts GM, Ford Debt to Junk
Cost Concerns Gain Focus
Ahead of UAW Negotiations;
Downgrade Follows S&P
By John D. Stoll and Joseph B. WhiteStaff Reporters of THE WALL STREET JOURNAL
General Motors Corp. and Ford Motor Co. took another hit as Moody's Investors Service downgraded the corporate debt of both auto companies to junk status, following similar moves by Standard & Poor's Corp.
The moves come as the top two U.S. auto makers by market share struggle with intense competition, high costs and the decline in sales of their biggest and most profitable sport-utility vehicles. Moody's downgrades, affecting about $150 billion of debt, will ratchet up pressure on GM and Ford to confront their cost problems in the U.S. before contract talks with the United Auto Workers union are to begin in 2007.
Over time, the downgrades to high-yield, or junk, status will make borrowing money more expensive for GM and Ford. The downgrades affect the auto makers and their big finance operations, although Moody's kept Ford's Ford Motor Credit Co. unit at investment-grade status.
A GM spokesman said the company is disappointed with Moody's decision and is committed to improving its performance. Still, he added, "we're starting to see signs of progress" on the company's recovery, including new products and successful marketing and sales campaigns.
In a statement, Ford Chief Financial Officer Don Leclair called Moody's decision "disappointing" and said the company is responding with actions to cut costs and strengthen the balance sheet. The auto maker said Tuesday that its Volvo Car Corp. subsidiary will slash between 1,000 and 1,500 jobs in an effort to save $130 million in 2005.