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Ans: A course of action parameter whose variability has an effect on a important good quality attribute and for that reason really should be monitored or managed to make sure the process generates the specified good quality.This segment is relevant only for orphan medicines. Necessary info on specifics and method are existing in “European Fee gui

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Both equally syrup concentrations According to IP and USP give stable syrup. Syrup made up of various concentrations of sucrose demands an antimicrobial preservative.To calculate the free water equal, the volume occupied through the sucrose, the amount preserved via the sucrose, and the quantity occupied and/or preserved by other additives has to b

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