What Does a Certificate of Analysis Tell You?


Quick Answer

A certificate of analysis certifies the quality and purity of pharmaceutical drugs, animal and plant products; the certificate is an official document that shows testing results on a particular food, drug or regulated product. A quality-assurance team issues the certificate to confirm that a particular product meets the proper specifications.

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Full Answer

A certificate of analysis is issued by a regulatory or quality-assurance organization to ensure product standards. The FDA requires manufacturers to provide certificates of analysis for each lot. The certificate frequently contains testing results like the quantity of chemicals within the product.

A certificate of analysis must contain items such as a material description, reference code and batch number, the purity and homogeneity of the product, the intended use of the product with instructions and safety information, explains Inorganic Ventures. The certificate notes traceability, reported values, the date of certification and the expiration date.

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