〈1788〉 Methods for the Determination of Subvisible Particulate Matter
It is the intent of USP general test chapters Injections and Implanted Drug Products 〈1〉 and Particulate Matter in Injections 〈788〉 that systems, packaging, and formulation be selected and developed with regard to commercial product cleanliness and stability. Monitoring and limiting particulate levels are an important effort in ensuring product quality and controlling the risk of adverse effects or loss of drug efficacy.