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Impurities Standards Supply

API & Drug Product Development >> API Development >> Impurity / Reference Standard

DIVERCHIM can supply its customer impurities standards, in response to the Health Agencies’ requirements for impurities definition and characterization.

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Synthesizing Impurities

API & Drug Product Development >> API Development >> Impurity / Reference Standard

State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

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Impurity Isolation and Identification

API & Drug Product Development >> API Development >> Impurity / Reference Standard

AMRI's scientists apply LC/MS as a profiling technique to systematically monitor process-related impurities and degradants.

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Reference Standards/Working Standards of Impurities

API & Drug Product Development >> API Development >> Impurity / Reference Standard

Reference standards / working standards of impurities and products can be qualified and characterized with the complete report for regulatory submission. We help in in-house impurity standard generation by means of Degradation and isolation or synthesis.

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Synthesis/Isolation of Impurities, Metabolites, Degradants

API & Drug Product Development >> API Development >> Impurity / Reference Standard

Maithili undertakes custom synthesis of key intermediates and active substances for innovator companies worldwide. We have the expertise in synthesizing diverse classes of molecules and offer gram to ton quantities in a cost-effective manner.

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Impurities, Metabolites & Related Research Materials

API & Drug Product Development >> API Development >> Impurity / Reference Standard

Building on our experience of API development we can supply reference standard impurities, metabolites and related research materials. Using our supply chain network we generally source advanced intermediates to facilitate rapid and cost effective supply of these materials

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Metabolite And Impurity Synthesis

API & Drug Product Development >> API Development >> Impurity / Reference Standard

Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

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Synthesis of Known / Unknown Impurities

API & Drug Product Development >> API Development >> Impurity / Reference Standard

With the help of deep Organic Chemistry knowledge along with state-of-the-art synthesis infrastructure, we offer synthesis services for known / unknown impurities.

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Impurity Identification

API & Drug Product Development >> API Development >> Impurity / Reference Standard

Catalent offers fully-validated, GMP Nuclear Magnetic Resonance (NMR) and Mass Spectrometric (MS) services, as well as other spectroscopic and thermal techniques for impurity identification.

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Control of Impurities

API & Drug Product Development >> API Development >> Impurity / Reference Standard

Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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