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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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Synthesis & Purification of Analytical Reference Standards

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

Our team of experts can custom develop processes, design and optimize routes and provide R&D screening services using our proprietary library of more than 600 enzymes.

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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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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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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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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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Reference Standard Characterization

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 reference standard characterization.

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Impurities, Degradants or Metabolites Isolation

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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