March 07, 2018
Particulate matter in injections is defined as extraneous particles, unintentionally present in the end product. These contaminants can come from various sources, including the environment, packaging materials and undissolved formulation ingredients. Particulate matter can be harmful when introduced into the bloodstream. Therefore, the US Pharmacopeia places limits on the amount of sub-visible particles that are allowed in both injections and ophthalmic solutions based on these risks, as described in USP<788> and USP <789>.