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For parenteral items, inspections have shown that where pyrogen problems were located in dosage kinds, and when the source was among the Uncooked resources, it had been the active drug compound. This was specifically true for drug substances in which system drinking water was utilised at some late phase while in the synthesis procedure.
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This identified benefit signifies that if a parenteral drug producer is using the LAL system for endotoxin tests of Cyanocobalamin Inj., the merchandise might have no more than 350 EU/ml of product.
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Fantastic exercise would come with small managing of the part immediately after washing and prompt sterilization specifically if sterilized by steam. Storing non-sterile soaked stoppers could lead on to a rise in microorganisms And maybe endotoxin concentrations.
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