Formulation Services

Analytical Services

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Chemistry

Alcami offers a broad range of analytical testing and related services

Alcami’s scientists have more than 40 years experience developing analytical methods and procedures to support drug development and manufacture. Equipped with first-in-class lab and process analytical technologies, our labs are flexible and designed to achieve optimal results in an efficient and timely manner.

Core Capabilities 

  • Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS

  • Analytical method development, verification, transfer, and validation studies for small molecules and biopharmaceuticals

  • Drug substance reference standard characterization studies

  • API characterization

  • Heavy metals, trace metal impurities, and elemental impurities testing per USP <232>, <233>

  • Organometallics

  • Catalyst Control

  • Residual solvents as per USP <467>

  • Container and closure system integrity testing by vacuum and pressure decay

  • Disinfectant qualification and disinfectant efficacy studies

  • Liquid chromatography

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