Drug Actives from Bench into Market.
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Girindus  can  provide  analytical  services  at  all  stages  of  the  drug  development

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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"The quality of the API is crucial to that of the medicine."