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 Dr. Anisfeld
Regarding the withdrawn stability study samples at study points, what is the allowable period and at what condition samples should be stored before starting analysis?
Answer 1, 2, and 3 months samples should be withdrawn and tested with 3 days of the target date;
6, 9, and 12 month samples should be withdrawn and tested within 7 days of the target date;
18, 24, 36 month samples should be withdrawn and tested with 14 days of the target date.
after withdrawal keep samples in refrigerator until tested,
