Residual Solvents Specifically address solvents List methods of assay, for Complies, but where limits that are included in the BP example: BP 2011 (Appendix exceed recommendations of Appendix VIII L. VIII L, Residual solvents; Ph pharmacopoeia monograph, Eur method 2.4.24). limits should be specified. Address any additional solvents that may be used in Solvent specific limits of any the production, preparation, solvents not specified in BP manufacturing or 2011 (Appendix VIII L) formulation. Add rows as necessary. Incidental metals and non-metals Specifically address the List methods of assay, for Limits of total heavy metals metals in the current BP or example: BP 2011 (Appendix Metal specific limits other default standard (Ph VII); Ph Eur method 2.4.8 or Eur, USP) limit test for heavy in-house. metals. Include total heavy metals and/or any limits for specific metals or non-metals, for example: lead, cadmium, mercury, arsenic, cyanide Add rows as necessary. Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) Specifically address the limits List methods of assay, for Complies stipulated in the current BP example: BP 2011(Appendix (or Ph Eur, USP), and XI L, Pesticide residues; Ph whether the product would Eur method 2.8.13). comply with these limits. In addition, state any additional residue limits that may be relevant. Add rows as necessary. organic or inorganic impurities or toxins Include other substances that List methods of assay, refer Limits of total impurities in may pose a safety risk, or to pharmacopoeial methods substance may be of therapeutic where possible, for example: Impurity specific limits significance. BP, Ph Eur, USP.
Residual Solvents Specifically address solvents that are included in the BP Appendix VIII L. Address any additional solvents that may be used in the production, preparation, manufacturing or formulation. Add rows as necessary. List methods of assay, for example: BP 2011 (Appendix VIII L, Residual solvents; Ph Eur method 2.4.24). Complies, but where limits exceed recommendations of pharmacopoeia monograph, limits should be specified. Solvent specific limits of any solvents not specified in BP 2011 (Appendix VIII L) Incidental metals and non-metals Specifically address the metals in the current BP or other default standard (Ph Eur, USP) limit test for heavy metals. Include total heavy metals and/or any limits for specific metals or non-metals, for example: lead, cadmium, mercury, arsenic, cyanide Add rows as necessary. List methods of assay, for example: BP 2011 (Appendix VII); Ph Eur method 2.4.8 or in-house. Limits of total heavy metals Metal specific limits Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) Specifically address the limits stipulated in the current BP (or Ph Eur, USP), and whether the product would comply with these limits. In addition, state any additional residue limits that may be relevant. Add rows as necessary. List methods of assay, for example: BP 2011(Appendix XI L, Pesticide residues; Ph Eur method 2.8.13). Complies organic or inorganic impurities or toxins Include other substances that may pose a safety risk, or may be of therapeutic significance. List methods of assay, refer to pharmacopoeial methods where possible, for example: BP, Ph Eur, USP. Limits of total impurities in substance Impurity specific limits
cm-forms-compositional-guideline-140722.docx