OUR SERVICES
Pharmaceutical Testing
Highly specific quantification of Active Pharmaceutical Ingredients. Includes identity confirmation via mass fragmentation, stability-indicating methods and trace-level detection in complex matrices.
Detection of organic, genotoxic and unknown impurities at ppm/ppb levels. Full structural identification support and compliance with ICH Q3A / Q3B / M7 guidelines.
Detection of NDMA, NDEA and other mutagenic impurities at trace levels (ng/g or lower). Full-spectrum coverage: raw material, in-process and finished product.
Drug quantification in plasma and serum, metabolite analysis and pharmacokinetic studies. The method of choice for clinical trials, therapeutic drug monitoring and technology.
High-throughput analysis of large sample volumes for drug concentration vs. time profiling. Supports PK modeling and required for generic drug regulatory approval.