From initial release of raw materials (for cGMP processes) to chromatography method development (or implementation of existing methodology from clients), through in-process testing, to the final release of product (intermediates or drug substance) by Certificate of Analysis.

Analyses are carried out in a cGMP/GLP compliant laboratory setting. In-house chromatography data acquisition and analysis software are 21 CFR Part 11 compliant.

Some of the testing available includes:

• In-process determination of reaction mechanisms via ReactIR.
• Reaction microcalorimetry to monitor heats of reaction and exotherms prior to scale-up.
• GC/MS to identify impurities.
• For release and IPC testing and can be carried out using a variety of in-house instrumentation including NMR, FTIR, DSC, polarimetry, HPLC (including photodiode array detection), GC, LC/MS, MALDI-TOF, Karl Fischer moisture analysis

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