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Degradation Impurities

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

Biondustria L.I.M's R&D Laboratories are in charge of synthesizing process and degradation impurities for analytical department and to support customers in developing their generics.

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.

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.

Impurity Synthesis

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

Eurofins CDMO offers services during the whole development process and manage impurities synthesis and control.

Impurity Profile Characterisation

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

Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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.

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.

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.

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.

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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