Nutraceutical Testing
Columbia Analytical is a registered contract testing laboratory providing cGMP-compliant testing to the raw material suppliers, CMOs, and product developers/sponsors of the pharmaceutical industry. To ensure regulatory compliance, Columbia Analytical is FDA inspected and registered and DEA licensed. We maintain a comprehensive quality unit that ensures all data is scientifically sound and accurately documented.
Monograph Testing
We use USP/NF, EP, JP, BP, AOAC and ACS compendial methods for raw material and final product testing.
Examples include:
- Residual solvents testing by USP <467>
- Moisture analysis by USP <921>
- Heavy metals by USP <231> and instrumental methods (AA, GFAA, ICP-AES, ICP/MS, HPLC-ICP/MS)
- Microbial testing
- Identification and quantification by chromatographic procedures (TLC, GC, HPLC, GC/MS, HPLC/MS/MS)

Method Development and Validation
Our professional scientists have extensive experience in analytical chemistry and routinely provide method development and validation for nutraceutical testing. Methods are validated to current USP/ICH guidelines.

Engineering Studies/Process Validation
Our scientists are accustomed to non-routine testing and have the knowledge and resources to solve your analytical problems. Examples of this may include analytical support for cleaning studies or manufacturing processes.
Stability Testing
Columbia Analytical provides analytical support to your stability study testing.
- Assay testing
- Physical testing
- Impurity and degradation product monitoring
- Development and validation of stability indicating assays

