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Identifying & Reducing Impurities

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

Pfizer's scientists reduced reaction time by ~ 30% using a range of PAT technologies to track processes to minimize impurity formation while maximizing batch yield.

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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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Impurities Testing for Pharmaceutical Products and APIs

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

From residual solvents and process-related impurities to extractables/leachables and degradant-related impurities, Eurofins BioPharma Product Testing offers a broad range of services in support of impurities testing.

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Impurities Assay

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

Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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Impurities and Related Substances

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

Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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Drug Substance Impurity Profiles

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

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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Impurity Profiling Methods

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

Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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Identification of Impurities with LC-MS (Q-TOF) and GC-MS

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

Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

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Assay & Purity Testing of products

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

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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