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Pharmaceuticals/Drug products packaged in semipermeable containers stability

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Question
Dear Dr.
what is the accelerated stability study for water loss for Drug products packaged in semipermeable containers, is it a 3months or 6 months?
it was recorded in the ICH Q1A that  A 5 percent loss in water from its initial value is considered a significant change for a product packaged in a semipermeable container after an equivalent of 3 months' storage at 40C/NMT 25 percent RH.

Answer
For water loss, at 3 month accelerated conditions under low humidity, a loss of over 5% is considered "significant" - but remember you need to provide data that the product is OK over the normal storage and shelf-life.

Having worked in Jordan and being aware of the desert climate and its low ambient humidity, this is a real concern. As 6-months is a better indicator of 2-years shelf life than 3-months accelerated data; I'd do my accelerated study for 6-months.

Good Luck.

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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