Accurate, reliable, cost-effective quality control testing for pharmaceuticals including Rx, OTC, Precursor Class A controlled substances, household and industrial disinfectants and sanitizers with disinfectant claims.
With an expansive array of advanced technology, combined with years of experience, we are able to provide the pharmaceutical industry with accurate and reliable testing results in a timely manner.
Our Health Canada registered facility exceeds all compliance standards for conducting pharmaceutical analysis. Our systems for sample log-in, testing and report generation have evolved to ensure complete and accurate GMP/GLP compliance.
Health Canada requires testing for certain human pharmaceutical products for detection, identification and quantification of nitrosamine impurities by Market Authorization Holders (MAHs). This requirement is part of Health Canada’s efforts to mitigate the risk of nitrosamine contamination for all active pharmaceutical ingredients (APls) and drug products containing chemically synthesized APls.
CAL provides testing for drug products, raw materials, and active pharmaceutical ingredients (APIs) to detect, identify and quantity the presence of following nitrosamines using LC/MS/MS:
- N-nitrosodimethylamine (NDMA)
- N-nitroso-diethyl amine (NDEA)
- N-ethyl-N-nitroso-2-propanamine (NEIPA)
- N-nitroso-diisopropylamine (NDIPA)
- N-nitroso-di-n-propylamine (NDPA)
- N-nitroso-methyl phenylamine (NMPA)
- N-nitroso-di-n-butylamine (NDBA)
- N-nitroso-N-methyl-4-aminobutyric acid (NMBA)
Contact our experts in LCS/MS/MS to discuss your specific requirements further.
Canadian Analytical Laboratories offers Thermogravimetric Analysis (TGA) for quantification of impurities in raw materials and active pharmaceutical ingredients to characterize and verify materials for QA/QC material specification requirements.
Impurity testing is typically a costly but necessary activity as regulations on pharmaceuticals have been lowering limits for impurities over the past several years. In so doing, this has necessitated detection methods to become more sensitive and selective resulting higher testing costs for pharmaceutical companies.
TGA provides a significantly more cost-effective approach as much smaller sample sizes are required to produce highly accurate and reproducible results.
We have developed in-house methods, as well follow compendial or client-provided methods. We also have deep expertise in developing new methods when no current method exists.
Our laboratory is licensed by Health by Health Canada to conduct controlled substances testing. Visit the Controlled Substances page to learn more.