Pharmaceutical Expertise

Our strong history in industrial gas and volatile testing, going back over 40 years, has led to us receiving requests to apply our expertise to the pharmaceutical sector. In this transition mode, we are mastering the ways of GLP and GMP (FDA compliance) and have been integrating these practices upon request. Such requests have been to develop and validate a superior method for certifying USP/NF Nitrogen by Mass Spectrometry, perform headspace GC, GC-MS, and GC-MS-MS on product containers; and to certify Hydrogen purity to 99.9995% from Hydrogen generators used in GC-FID experiments. In addition, we perform small-scale de-novo synthesis of small-molecule synthetic reagents, primary standards and chemical markers for pharmaceutical, biotechnology, clinical and contract research organizations (CROs). These compounds can be with or without isotopic labeling, and their Certificate of Analysis (CoA) includes the four (4) principal spectroscopic techniques (MS, NMR, IR, and UV).

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