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Impurities & Working Standards - Pharmaffiliates

Impurities are unwanted chemicals present in the API or FPP arising from normal manufacture.A particular manufacturer's manufacturing method may lead to unexpected impurities, due to a different route of synthesis, different reagents, etc<br>

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Impurities & Working Standards - Pharmaffiliates

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  1. In-house Impurities of Pharmaffiliates • Impurity Synthesis • Metabolite Synthesis • Working Standards • Deuterated Compounds Corporate Presentation2017 Pharmaffiliates

  2. In-house Impurities: • Impurities are unwanted chemicals present in the API or FPP arising from normal manufacture. • Impurities have no therapeutic value and are potentially harmful. Therefore they need to be controlled. • A particular manufacturer's manufacturing method may lead to unexpected impurities, due to a different route of synthesis, different reagents, etc. • Unfortunately no, monographs are developed based upon how the API was prepared historically. • Most of the potential impurities arise during the preparation of the API and its subsequent degradation. • Consequently, there is a large focus on the control of impurities in the API. • Genotoxins must be considered carefully due to their toxicity at even very low levels. Corporate Presentation2017 Pharmaffiliates

  3. When To Specify IMPURITIES The ICH Q3 divides impurities into following categories. • Organic impurities (process- and drug-related) • Residual solvents • Inorganic impurities • Metallic impurities Corporate Presentation2017 Pharmaffiliates

  4. Advantages of Pharmaffiliates Impurities: • Option to customer for lower pack sizes of 25 mg and 50 mg • Options of Customized pack sizes • More number of Compounds and largest inventory holder presently • Option of supply/availability of compounds which are presently not listed in present catalogue • All the Impurities supplied with complete structure elucidation and interpretation i.e. IR, NMR , MASS and Chromatographic purity along with detailed COA • Majority of the Impurities are above 98% pure • Capability of synthesis typical compounds like Dimers, Isomers and Unknown Impurities • ISO 17025 & USFDA accredited company also applied for ISO 34 • Global presence in more than 45 countries Corporate Presentation2017 Pharmaffiliates

  5. Corporate Presentation2017 Pharmaffiliates

  6. Corporate Presentation2017 Pharmaffiliates

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