Transcription of 5.7 TESTS FOR PARTICULATE CONTAMINATION - …
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5.7 TESTS FOR PARTICULATE CONTAMINATION - …
March 2012 TESTS FOR PARTICULATE CONTAMINATION : Final text for revision of The International Pharmacopoeia (March 2012) This monograph was adopted at the Forty-sixth WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2011 for revision of the text published in the 4th Edition of The International Pharmacopoeia. TESTS FOR PARTICULATE CONTAMINATION PARTICULATE CONTAMINATION of injections and parenteral infusions consists of extraneous, mobile, undissolved particles, other than gas bubbles, unintentionally present in the solutions. The types of preparations for which compliance with these TESTS are required are stated in respective general monographs.
QAS/11.405/Final page 2 products that produce air or gas bubbles when drawn into the sensor may also require microscopic particle count testing.
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