Identification The identification test(s) List methods of Complies, for example: must be able to identification. Refer to matches spectrum of unambiguously distinguish pharmacopoeial methods authenticated reference the substance from any other where possible (attach material. substance, and may include details of proprietary tests such as methods). ‘fingerprint’ TLC, HPLC or IR which must be compared to an authenticated reference material. More than one test may be appropriate. For pure substances, chromatographic retention time alone is generally considered inadequate as a method of identification. Add rows as necessary. Describe test(s) that State and if necessary Limits for assay(s) taking determine the presence and describe methods of assay or into account practical but quantity of a specific provide brief details. reasonable biological, substance. In case of herbal physical and chemical materials, preparations, or variation. other complex mixtures (for example: herbal extracts), appropriate marker compounds may be assayed. Add rows as necessary. Notes * The residue on ignition test and sulphated ash test are appropriate as characteristics when performed on inorganic material. For organic substances, the test should be included under organic or inorganic impurities or toxins”. “Other Table 2. Incidental constituents Where justified, certain tests for incidental constituents may be excluded based on the origin and processing of the substance, for example: a dried leaf, otherwise unprocessed, may be exempted from residual solvent testing. Other incidentals, such as scheduled contaminants (for example: bromides, ephedrine) or radioactivity should be included where appropriate. Test Method reference Acceptance criteria
Identification The identification test(s) must be able to unambiguously distinguish the substance from any other substance, and may include ‘fingerprint’ tests such as TLC, HPLC or IR which must be compared to an authenticated reference material. More than one test may be appropriate. For pure substances, chromatographic retention time alone is generally considered inadequate as a method of identification. Add rows as necessary. List methods of identification. Refer to pharmacopoeial methods where possible (attach details of proprietary methods). Complies, for example: matches spectrum of authenticated reference material. Describe test(s) that determine the presence and quantity of a specific substance. In case of herbal materials, preparations, or other complex mixtures (for example: herbal extracts), appropriate marker compounds may be assayed. Add rows as necessary. State and if necessary describe methods of assay or provide brief details. Limits for assay(s) taking into account practical but reasonable biological, physical and chemical variation. Notes * The residue on ignition test and sulphated ash test are appropriate as characteristics when performed on inorganic material. For organic substances, the test should be included under “Other organic or inorganic impurities or toxins”. Table 2. Incidental constituents Where justified, certain tests for incidental constituents may be excluded based on the origin and processing of the substance, for example: a dried leaf, otherwise unprocessed, may be exempted from residual solvent testing. Other incidentals, such as scheduled contaminants (for example: bromides, ephedrine) or radioactivity should be included where appropriate. Test Method reference Acceptance criteria
cm-forms-compositional-guideline-140722.docx