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Pharmaceuticals/in use stability testing

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Question
Dear Mike
I know as per the guidelines that some products especialy reconstituted ones should be monitored for their stability after reconistitution over a period that mimic the practice....
For a multidose product in the form of ointment or cream that is always opened by the user and kept for a time till used again then stored and reused more than a time....should it be subjected to an in use stability study??...If yes how and FOR HOW LONG should it be followed after first opening...wishing you all the best. M. Etman

Answer
The answer in a word is YES.

And, this is important, ensure that the USP or the Ph.Eur. "Antimicrobial Effectiveness Test" is performed at each stability time point. When performing this test, use the same tube of ointment at all stability time points, squeeze some ointment out for the test, seal the tube again, and at the next time point take a sample from the same tube (thus simulating usage of the ointment)

I hope this helps,
Good Luck,
Michael Anisfeld

Pharmaceuticals

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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