A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter

By Mark Hallworth

A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. The document’s changes are a valuable orthogonal method that provides complimentary morphology information. Enhanced knowledge of particle type aids in the determination of contamination source and potential correction, if found to be of adverse levels.

The document’s changes are a valuable orthogonal method that provides complimentary morphology information. Enhanced knowledge of particle type aids in the determination of contamination source and potential correction, if found to be of adverse levels.

Pharmaceutical injectable products are available in several forms. In each case, the insoluble component needs to be evaluated regarding contamination. Here we explore the applicability methods, particle count limits, test method influences and more.