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For parenteral solutions, inspections have demonstrated that the place pyrogen troubles were being found in dosage kinds, and in the event the supply was one of several raw resources, it had been the active drug material. This was especially real for drug substances during which approach drinking water was applied at some late stage within the synthesis procedure.
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This determined value implies that if a parenteral drug maker is using the LAL process for endotoxin screening of Cyanocobalamin Inj., the products may have no more than 350 EU/ml of merchandise.
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