Particulate matter in injections physical tests usp 35 for preparations supplied in containers with a nominal ysis by either test method. These standard particles are dispersed in particlefree water. Particulate matter in ophthalmic solutions 353 average. Manual method adjust the particle counter to operate in the cumulative mode or total count. Usp particulate matter in ophthalmic solutions entegris. Every ophthalmic solution for which the monograph includes a test for particulate matter is subject to the particulate matter limits set forth for the test being. Usp requirements and particle identification parenteral drug.
Light obscuration and microscopic procedures for the determination of particulate matter in ophthalmic solutions are identical to those for injections. The general chaptersdosage forms expert committee proposes this new. The national institute for occupational safety and health niosh considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or. The general chapter particulate matter in injections revision bulletin supersedes the currently official version published in the usp 35nf 30 and will be incorporated in usp 36nf 31. Care must be taken to avoid aggregation of particles during dispersion. Regulatory perspective on key usp general chapters in. General precautions the test is carried out under conditions limiting particulate matter, preferably in a laminarflow cabinet. Delete crossreferences to general chapter heavy metals from.
Should you have any questions, please contact desmond hunt, ph. For the determination of product acceptability, apply the limits for the membrane microscopic test in general chapter a788n. Objectives by the end of this presentation you should be able to. The usp particulate matter in ophthalmic solutions test is used to quantify the count and size of subvisible particles in eye care products. For preparations supplied in containers with a nominal ysis by either.
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