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
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Expert: Michael Anisfeld Date: 4/29/2008 Subject: Raw Material storage requirements
Question what is meant by "Store in cool and dry place" in pharmaceutical raw material storage. We often use certain raw materials that contain the storage requirement as cool and dry place on either bag or on MSDS. Please let me know what temp. range is required for storage these maaterials?
Thanks
Irfan Ali Zeb
Answer Irfan:
According to USP definitions (USP31):
"Cool" — Any temperature between 8oC and 15oC (46 and59 F). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.
"Dry Place" — The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity.
Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place.
