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 <788> Particulate Matter in Injections, <789> Particulate Matter in Ophthalmic Solutions, and <787> Sub-visible Particulate Matter in Therapeutic Protein Injections.
With the advent of Flow Imaging technologies and new therapeutic protein solutions, the document’s scope was widened. Changes include 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’ 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:
- <1788> Methods for Determination of Subvisible Particulate Matter
- <1788.1> Light Obscuration Method for the Determination of Subvisible Particulate Matter
With the advent of Flow Imaging technologies and new therapeutic protein solutions, the document’s scope was widened. Changes include 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.
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