Analytical Services and API Quality Research

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Analytical Services and API Quality Research

Analytical Services and API Quality Research


  1. Study of Impurities: identification and preparation of unknown impurities;

  2. Genotoxic Impurity Evaluation and Analytical Method Development andvalidation for Trace level Analysis in API;

  3. Full Capability for GMP Release of API;

  4. Other service:

    • HPLC Impurity Profile

    • Assay by HPLC, GC and/or Titration

    • API Counter Ion Content by Ion Exchange HPLC

    • Residual Solvents by HS-GC

    • Enantiomeric Purity by Chiral HPLC

    •  Quantitation of Trace Level of Genotoxic Impurities