CLS offers a broad range of analytical testing and related services including the following listed.
- Compendial monograph testing as per the USP, EP, BP, JP, FCC, ACS, IP etc.
- Analytical method development, verification, transfer, and validation studies for pharmaceutical APIs and formulations etc., as per ICH Q2, USP, method verifications as per , and/or customer requirements.
- Drug substance reference standard characterization studies
- Residual solvents as per USP
- Elemental Impurity analysis as per USP General Chapter, ICH Q3D, EMA Guideline and/or customer requirements.
- Analysis of Raw Materials, Key starting materials (KSM), Intermediates Drug substances and formulations.
- Unknown impurity profiling studies.
- Chemical characterization studies.
- EO, ECH and EG residual studies as per ISO 10993-7.
