White Paper

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

By Mark Hallworth

magnifying glass w pills 450x300

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.

VIEW THE WHITE PAPER!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of ECM Connection? Subscribe today.

Subscribe to ECM Connection X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to ECM Connection