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USP 62 Absence of Bile Tolerant Gram Negative Bacteria refractometer A sufficient representative sample must

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Description

A sufficient representative sample must be collected from every lot received in every unique shipment

quality and purity is met

or with simulated in-use

Returned or reprocessed drug product shall be destroyed unless examination

USP 62 Absence of Bile Tolerant Gram Negative Bacteria refractometer A sufficient representative sample mustSOP and report form for the test to prove the absence or presence of bile tolerant gram ve coliforms in products according to harmonized method USP <62> and EP 2. 6. 13

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