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A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement

Format: PDF file | Document type: White / Technical Paper
A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement

The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the history of the test, the benefits of the change and considerations for validation of the LC approach to analysis.