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Pharmaceuticals/Freeze Thaw Study

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Expert: Michael Anisfeld - 9/20/2008


Question
Dear Sir,
I would like to know how is freeze/thaw study carried out for Liquid oral products with references, if any.
Thanks in advance

Answer
Take your liquid product, cool at -5oC to freeze, and hold frozen for 24 hours; then thaw at room temperature and hold in liquid conditions for 24 hours. repeat this cycle twice more (hence total of 3 freeze-thaws). Then place onto ICH stability conditions and perform stability study (accelerated or room temp.)

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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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