Impurity identification

Recipharm has extensive experience and a wide range of analytical and synthetic equipment to conduct successful impurity identification for pharmaceutical products.

According to the ICH Q3A(R2) and Q3B(R2) guidelines, impurities in any dosage form, or API, must be identified during the product development. Additionally, any degradation product, observed in stability studies at recommended storage conditions, at a level greater than the identification threshold should also be identified.

Our impurity identification services include:
  • Development of a mass spectrometry (MS)-suitable ultra performance liquid chromatography (UPLC) method for the separation of the examined impurity
  • High resolution mass spectrometry (HRMS) analysis for the determination of molecular weight and formula of the impurity using a QTof mass spectrometer
  • Fragmentation mass spectrometry (MS/MS) analysis of the impurity and related compounds for the structure elucidation of the impurity
  • Verification of the structure-MS/MS spectrum consistency based on ion thermochemistry using the NIST MS Interpreter 2.0 software
  • Isolation of the impurity, from the drug product, using preparative high performance liquid chromatography (HPLC)
  • Nuclear magnetic resonance (NMR) analysis for the structure elucidation of the impurity
  • Proposition of the molecular structure of the examined impurity on the basis of the MS/MS and NMR analyses results
  • Chemical synthesis of the reference material with the proposed structure
  • Confirmation of the proposed structure by comparative UPLC-MS/MS analysis employing the synthesised reference material
  • Suggestion of the impurity origin and its formation pathway

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