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For parenteral products, inspections have revealed that where pyrogen issues were being present in dosage kinds, and if the resource was one of the raw resources, it was the Energetic drug material. This was specifically true for drug substances in which approach h2o was applied at some late stage during the synthesis course of action.
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Some finished products and solutions examined, Though not found actionable due to minimal dose of product or service to get administered, might be indicative of pyrogen complications in other methods, such as a H2o for Injection Technique.
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