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In the impurity research work of compound preparations, it is necessary to adopt appropriate methods to analyze and determine the source of each impurity, conduct qualitative research and attribute it, because the determination of the impurity limit must be based on a clear attribute. For example, for toxic impurities, it is necessary to clarify the […]

Part 1 worst Condition   Theoretically, the different equipment involved in each variety should have its own cleaning operation procedures confirmed. However, in the practice of drug production, it is impossible and unnecessary for enterprises to spend manpower, material resources, and financial resources to confirm all the equipment involved one by one. This requires enterprises

Leakage of highly active drugs will seriously endanger the safety of operators – therefore, as more and more highly active compounds are approved as new drugs, pharmaceutical companies have more and more requirements for the closed production of tablet drugs . Drugs of OEB 3 level (OEL<100 µg/m3) need to be evaluated during the production process