Part 1 Definition And Source Of Impurities Impurities can be defined as mixtures of target components with extraneous or inherently inferior substances. It is often the final manufacturing process that has a major impact on the cost of the API. Yield, physical properties, and chemical purity are key considerations in API production, preparation formulation, […]
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The freeze-dried products of biological products need to have a certain physical form; uniform color, qualified residual moisture content, good solubility, high survival rate or potency, and long storage period. Therefore, it is not only necessary to control the seedling making process and the sealed storage after freeze-drying. What is more important is to fully
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Part 1 Overview Of Sterilization Of Sterile Drug Products Sterilization method refers to the method of killing or removing all surviving microbial propagules or spores by physical and chemical methods to make the sterilized items sterile. In the production of sterile drugs, the prevention of endotoxin contamination and microbial contamination has always been the
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