Abstract
Provisional, unofficial monographs are developed by the Drug Standards Laboratory, in cooperation with the manufacturers of the drugs concerned, for publication in the Journal of Pharmaceutical Sciences. The ready availability of this information affords discriminating medical and pharmaceutical practitioners with an added basis for confidence in the quality of new drug products generally, and of those covered by the monographs particularly. Such monographs will appear on drugs representing new chemical entities for which suitable identity tests and assay procedures are not available in the published literature. The purity and assay limits reported for the drugs and their dosage forms are based on observations made on samples representative of commercial production and are considered to be reasonable within expected analytical and manufacturing variation.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
