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Pharmaceuticals/correlation between API shelf life and formulation finished product shelf life?

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Question
Based on stability studies, we have fixed the shelf lives of our Hormonal product (Tablets) expiry at 2 years. I have an API which is remaining with a shelf life of 3 months. What shelf life would you recommend if I use it for formulating my product.What is the correlation between API shelf life and formulation finished product shelf life?

Answer
India is unique in stating (Schedule M) that the product shelf life cannot be longer than the shelf life of the active ingredient. No other country has such a regulation, and all rely on your demonstrated product stability study (expiration dating).

The answer to your question depends on where you are marketing the product, and the regulations that apply.

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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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