Drug Product Assay

An extensive set of analytical testing and acceptance criteria is applicable to drug products –including universal and specific test criteria established by ICH Q6 guidelines and methods described in the specific monograph for the finished dosage form. All drug substances should undergo a specific, stability-indicating assay to determine their strength and content.

In many cases it is possible to employ the same procedure (e.g., HPLC) for both assay of the new drug substance and quantitation of impurities. Results of content uniformity testing for new drug products can be used for quantitation of drug product strength, if the methods used for content uniformity are also appropriate as assays.

All drug products must be GMP compliant before release for commercial use. We provide the tools you need to release safe and effective medicines, giving you peace of mind when it comes to audits.