Laboratory Services

Chemistry Services

Analytical Services
Formulation Development
Routine & Custom Testing

Alcami offers a broad range of analytical testing and related chemistry services

Alcami’s scientists bring over 40 years of expertise in developing analytical methods and procedures for drug development and manufacturing. With our experience in providing a variety of Chemistry services, we understand the complexities of regulatory and analytical processes and strive to be a strategic partner to support all your analytical development and testing needs. Our labs, outfitted with cutting-edge analytical technologies, are designed to be adaptable, ensuring optimal results are achieved efficiently and promptly.

Chemistry Services 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

Analytical Services, Formulation Development, Routine & Custom Testing

Summary

Alcami offers a broad range of chemistry and analytical testing services for pharmaceutical products. With decades of experience, they provide method development, validation, and routine testing to support drug development and manufacturing. Their services include compendial testing, impurity analysis, and container closure integrity, ensuring product quality and compliance.

Analytical Services, Formulation Development, Routine & Custom Testing

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