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Establishment of HPLC Selectivity by Stress Studies

Finally, impurity analysis can also be utilized to demonstrate illegal use of patented reaction routes. The impurity profile of a drug substance is influenced by the synthetic route and the source and quality of the starting materials. Identification of impurities in drug prepared by two different manufacturers may provide valuable insight into the manufacturing route and determine if patent infringement has occurred, because certain impurities may be indicators of a specific synthetic route. [Pg.665]

According to the ICH guideline on stability testing, the purpose of stress testing is twofold [45]. First, it can be used to predict the stability of the molecule and from the degradation products establish degradation pathways. Second, it can validate the stability-indicating capability of the analytical [Pg.665]


See other pages where Establishment of HPLC Selectivity by Stress Studies is mentioned: [Pg.665]    [Pg.667]    [Pg.669]   


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By HPLC

Establishing

Stress studies

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