(1993; 36 pages)
2.1. Quality specifications for drug substances and dosage forms
The Committee was pleased to note that publication of Volume 4 of The international pharmacopoeia, containing additional monographs on pharmaceutical substances, excipients and dosage forms together with supporting test methods and general requirements, was expected in 1993.
The Committee considered, and recommended for inclusion in a future publication, monographs on ophthalmic drops and ointments and on suppositories, and test methods for the disintegration of suppositories and for the sterility of non-injectable preparations. It noted the progress made jointly with experts from the European Pharmacopoeia Commission on developing a test for visible particulate matter in injectable preparations.
The Committee confirmed that the requirements of The international pharmacopoeia should continue to be based on reliable methods widely available in small control laboratories. Such a policy is consistent with the unique role of The international pharmacopoeia. However, in some circumstances, the provision of more complex methods as alternatives might be considered.
It was suggested that it would be helpful for WHO to obtain information about users of The international pharmacopoeia in order to ascertain more precisely by whom and for what purposes it is currently used.