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Analytical Method Development

Analytical >> Analytical Method Development >> Method Development and Validation

With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

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Screening of Chiral Stationary Phases & Method Development for Preparative Resolution

Analytical >> Analytical Method Development >> Chiral HPLC & SFC Method Development

AMRI provides HPLC screening of chiral stationary phases from diverse manufacturers to ensure the achievement of appropriate selectivity and quantitation limit. AMRI also offers chiral SFC method development as a complement to chiral HPLC.

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Analytical Validation

Analytical >> Analytical Method Development >> Method Development and Validation

In accordance with the ICH Q7 and the cGMP guidelines, DIVERCHIM validates the analytical methods developed by its teams to ensure registration and marketing authorizations by Health Agencies.

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Analytical Methods & Equipment Validation

Analytical >> Analytical Method Development >> Method Development and Validation

Among others, our analytical centre provides these methods and equipment: Analytical methods and equipment are validated; LCMS, GCMS, HPLC, TLC; UV/VIS and IR spectrometry; Capillary electrophoresis; Thermal analysis – DSC, Calorimetry; NMR (400 MHz) + xRAY; Particle-size distribution analysis.

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Development & Validation of Analytical Methods

Analytical >> Analytical Method Development >> Method Development and Validation

Menadiona's services also can include development and validation of analytical methods, filing of drug master files and regulatory support.

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Analytical Method Development & Validation

Analytical >> Analytical Method Development >> Method Development and Validation

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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Analytical Method Development & Validation

Analytical >> Analytical Method Development >> Biologic Drugs

AMRI specializes in biochemical method development, transfer and validation for the analyses of biological products and biosimilars by HPLC, UPLC, LC-MS, MALDI-TOF MS, NMR and assays.

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Purify & Characterize Process Impurities

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

Thanks to its innovative techniques (HPLC, SFC or combined preparative HPLC/SFC), DIVERCHIM proposes to its customers to isolate, purify and characterize process impurities as well as reference compounds.

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Impurity Profile Studies

Analytical >> Analytical Method Development >> Impurity Isolation and Identification

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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Method Development & Validation

Analytical >> Analytical Method Development >> Method Development and Validation

AMRI's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer — covering procedures for active pharmaceutical ingredients, drug formulations, cosmetics, personal care products and raw materials.

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