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During design of an API manufacturing process degradation of drug is noted following drying on heated shelves in an oven at 60oC. Upon investigation and
During design of an API manufacturing process degradation of drug is noted following drying on heated shelves in an oven at 60oC. Upon investigation and sampling, degradation is not throughout the batch but only in sections. Also degradation was not observed in the material discharged from the filter prior to drying. Explain process parameters that may contribute to degradation? Purpose an alternate drying process that could prevent degradation and explain rationale for drying process selected
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