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.

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.

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.

Developing Analytical References & Impurities

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

M2i coveres all needs from a few milligrams (leads, analytical references, impurities, etc.) to several kilograms (kilolab batches) thanks to its multipurpose equipment (reactors ranging from 250 mL to 50 L, temperature range from -40 °C to +165 °C).

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.

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.

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.

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 Standards

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

Our team of experienced Scientists has expertise in the custom synthesis of a wide range of small molecules like API, stable isotope labeled compounds, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities.