AboutMichael 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
Experience
Past/Present Clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
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.)
