Impurity Profiling of Drugs and Pharmaceuticals
New Analytical Methods- Development and Validation
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Drug Impurity Profiling: The need to develop new analytical methods for assurance of quality, safety and efficacy of drugs and pharmaceuticals is quite important because of their use not only as health care products but also life saving substances. The analytical methods assume of great importance due to i) development of new drugs ii) continuous changes in manufacturing processes for existing drugs and iii) setting up of threshold limits for individual and total impurities of drugs by regulatory authorities. Keeping this in view, an attempt was made in the present investigation to develop new...
Drug Impurity Profiling: The need to develop new analytical methods for assurance of quality, safety and efficacy of drugs and pharmaceuticals is quite important because of their use not only as health care products but also life saving substances. The analytical methods assume of great importance due to i) development of new drugs ii) continuous changes in manufacturing processes for existing drugs and iii) setting up of threshold limits for individual and total impurities of drugs by regulatory authorities. Keeping this in view, an attempt was made in the present investigation to develop new analytical methods for some of the important drugs and pharmaceuticals of 1-adrenergic receptor antagonist, antidepressants, cardiovascular agents, antioxidants and tuberculostatics in nature. All the methods described in the book are simple, rapid, reliable and validated. The methods could be used not only for quality control but also for process development of bulk drugs. The work carried out in the present investigation was described in six chapters.
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