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Impurities analytical methodology

Clinical trials of these orally active progestins showed that they were effective as contraceptives with a success rate that exceeded 99%. These compounds were then marketed as obtained from the reaction sequence after appropriate purification. As the analytical methodology improved it became apparent that a small amount of an impurity was present in all active samples. An examination of the reaction scheme allowed ready identification of that by-product. Any unreduced estradiol methyl ether (13-1) will go to estrone methyl ether on oxidation this will then afford the potent orally active estrogen mestranol (9-1) on ethynylation. Subsequent... [Pg.129]

The relatively free-wheeling synthesis selection phase through the END gives way to a much more controlled development phase, wherein the quality of the Toxicology Batch (and especially impurity levels) dictates the quality of the API batches to be produced, slowing process change. Analytical methodologies and specifications for the API, intermediates, and raw materials become more refined. Impurity and stability profiles are established. Process control mechanisms are developed and plant SOPs incorporate the better controls. The NDA process slowly takes shape. [Pg.139]

Baertschi, S.W. Analytical methodologies for discovering and profiling degradation-related impurities. Trends Anal. Chem. 25, 758-767 (2006)... [Pg.198]

VIII. ANALYTICAL METHODOLOGY FOR IMPURITIES IN DRUG PRODUCT... [Pg.27]

Q2(R1) Validation of Analytical Procedures Text and Methodology Impurities... [Pg.60]


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See also in sourсe #XX -- [ Pg.33 , Pg.34 , Pg.35 ]




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Analytical methodology

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