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The purity is the most important issue in API and takes decisive part in licensing process. Even small amounts of unwanted chemicals may change the efficacy and moreover the safety of drug product. The International Conference on Harmonization (ICH) has formulated a workable guideline regarding the control of impurities. The current tendency of regulatory authorities is to be more rigid to requirements concerned API purity. The control and qualification of the impurities is non routine process of acquiring and evaluating data, thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research. Dedicated reference standards for impurities can help in the development and validation of analytical methods for impurity control, and are also used in the routine analysis of drug products. The use of such standards can provide an accurate assessment of products against regulatory limits and thereby ensures appropriate onward actions, be these data submission, process improvement or preclinical evaluation.
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