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This kind of carryover shouldn't result in the carryover of degradants or microbial contamination which could adversely change the proven API impurity profile.Equipment should be constructed so that surfaces that Speak to Uncooked materials, intermediates, or APIs never change the quality of the intermediates and APIs over and above the Formal or o

Remodeling: Subjecting an intermediate or API that doesn't conform to requirements or technical specs to one or more processing steps which might be unique within the founded manufacturing method to get appropriate top quality intermediate or API (e.g., recrystallizing with a special solvent).Deal Maker: A company who performs some element of manuf