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USP 1788 Methods Review
In May 2021 a revision to USP 1788 Methods for Determination of Subvisible Particulate Matter was published, its aim is to aid in clarification and support of the information given in chapters USP 788 Particulate Matter in Injections, USP 789 Particulate Matter in Ophthalmic Solutions, and USP 787 Sub-visible Particulate Matter in Therapeutic Protein Injections. It was previously titled, Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions, and was focused on the validation and instrument requirements of Light Obscuration instruments and microscopic methods variability. However, with the advent of Flow Imaging technologies and new therapeutic protein solutions, the scope 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.
Particle Measuring Systems’(PMS) APSS-2000 testing system fully complies with the requirements for use in the testing of solutions in the Normative Chapters:
- <788> Particulate Matter in Injections,
- <789> Particulate Matter in Ophthalmic Solutions and
- <787> Sub-visible Particulate Matter in Therapeutic Protein Injections
And complies with the requirements in the General Chapters:
- USP 1788 Methods for Determination of Subvisible Particulate Matter
- USP 1788.1 Light Obscuration Method for the Determination of Subvisible Particulate Matter
