Instrumentation
Geneva Laboratories’ Chemistry Department is equipped with a variety of major instrumentation to meet your testing needs. This includes:
- Gas chromatographs with FID/TCD detection and headspace capability
- High performance liquid chromatograph (HPLC) with variable wavelength UV detection
- Total organic carbon (TOC) analyzer
- Osmometer (freezing point depression)
- UV-visible spectrophotometer
- Turbidimeter
- Autotitrator (Karl fisher, acid/base, precipitation titrations)
- FTIR spectrophotometer
- Polarimeter (optical rotation, specific rotation)
- Atomic absorption spectrophotometer
Compendial Testing
Geneva Laboratories’ chemistry department provides quality compendial and non-compendial chemical analysis of raw materials and final product. Compendial testing of pharmaceuticals (APIs and drug products), food additives, and reagent chemicals is performed under one of the following compendia:
- United States Pharmacopoeia/National Formulary
- European Pharmacopoeia
- Japanese Pharmacopoeia
- Food Chemicals Codex
- American Chemical Society Reagent Chemicals, 10th edition
Geneva Laboratories is DEA registered for handling Class II, Class III, and Class IV controlled substances. While most testing is performed according to USP monographs, we can develop and validate methods for controlled actives and the drug products made with them. Recent samples of controlled substances have included opiates, benzodiazepines, and anabolic steroids.
Method Development/Validation
Method Development/Validation services are offered for residual solvents testing for individual APIs and drug products, API and preservative assays in drug products, and impurities in APIs and drug products. These services are also offered for materials and/or testing requirements that are not covered by compendia specifications.
Validation of methods developed by Geneva Laboratories is performed according to the requirements in USP general chapter <1225>. Validation studies include determination of the linearity, range, accuracy, repeatability, and intermediate precision of the method. For residual solvents and impurities methods, validation also includes determination of the limit of detection and the limit of quantitation.
Ethylene Oxide Residuals
Geneva Laboratories is able to test for EO sterilization residuals in medical devices for both FDA (ppm limits) and ISO 10993-7 compliance. Headspace and water extraction methods can be run depending on the device category. Note that headspace extraction can only be used for EO, not ECH or EG, as their boiling points are too high for headspace sampling to be effective.