Dr Julia Griffen, Cobalt Light Systems; Dr Phil Doherty, Process Analytics Ltd; Dr Gemma Robinson,
Acorn Regulatory Consultancy Services Ltd.
Transmission Raman spectroscopy (TRS) is an alternative to HPLC for content uniformity (CU) analysis that has many attractive benefits, and is increasingly being used by pharmaceutical manufacturers for CU testing. TRS takes seconds per sample, is robust to sample variation, needs no preparation, solvents or consumables and saves significant cost and resource per batch. An important factor for adoption of the technique is the regulatory approval of TRS CU methods and, as submissions are made with regulators, it is important to take the correct strategy.
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