For excipients described in a pharmacopoeia:
Provide a copy of the monograph together with any test methods referenced but not duplicated in the monograph. Provide details of any specifications additional to those in the pharmacopoeia.
Excipients not described in a pharmacopoeia:
Provide a list of tests and limits for results for each excipient, including solvents, liquids to adjust pH, coatings, capsule shell, and inked imprint (on the dosage form), including description of test methods in sufficient detail for them to be replicated by another laboratory.
Include microbiological limits for materials of natural origin.
Only colours permitted by the EU’s “List of permitted food colours”3, the FDA’s “Inactive ingredient guide”4 or “Japanese Pharmaceutical Excipients”5 may be used.
3 List of permitted food colors, Official journal of the European Communities, 1994. L237. (European Commission Directive 94/36/EC).
4 Inactive ingredient guide. Rockville, MD, United States Food and Drug Administration, Division of Drug Information and Research, 1996.
5 Japanese pharmaceutical excipients. Tokyo, Pharmaceutical and Cosmetics Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare (updated annually or biennially).