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Question
my question is how we give expiry date to a finished dose form product, and if we have an API lot which expires in 2 months can we use this in formulating the finished dose if we can use then how can give an expiry of 2 yeas or more to the finished dose?
With the exception of products sold in India (they have a unique interpretation of API stability and its impact on product), you can use an API prior to its retest date. The API retest date has nothing to do with the expiration dating of the finished drug product.
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Answers by Expert:
Michael Anisfeld
Expertise
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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