Your Compound. Our Commitment.
Alcami’s scientists have more than 30 years experience developing analytical methods and procedures to support drug development and manufacture. Equipped with first-in-class lab and process analytical technologies, Alcami’s labs are flexible and designed to achieve optimal results in an efficient and timely manner.
Alcami offers a broad range of analytical testing and related services including the following listed.
- 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
- Active pharmaceutical ingredient (API) characterization
- Heavy metals, trace metal impurities and elemental impurities testing
- Residual solvents as per USP <467>
- Container and closure system integrity testing
- Disinfectant qualification and disinfectant efficacy studies
- Element impurities per USP <232>, <233>
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