Analytical Development

Our state-of-the-art analytical laboratory supports the entire drug development lifecycle, ensuring robust data integrity, accuracy and compliance with global regulatory expectations.

Comprehensive Analytical Services

  • Method Development & Validation – Custom analytical method development for assay, dissolution, impurities, and degradation studies.
  • Stability Studies & Forced Degradation – Conducting long-term, accelerated, and in-use stability studies per ICH guidelines (Zone I to Zone IV and so far).
  • Raw Material & Finished Product Testing – Ensuring identity, purity, potency, and microbial safety.
  • Dissolution & Bioequivalence Support – Critical studies for bioavailability and pharmacokinetics assessment.

Advanced Analytical Techniques

  • Chromatography & Spectroscopy – HPLC, UPLC, GC, LC-MS/MS, ICP-MS, and NMR for precise characterization.
  • Elemental & Impurity Profiling – Nitrosamine risk assessment, genotoxic/teratogenic impurity assessment and ICH Q3D compliance.

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Who We Are

Founded in June 2022, APDM Pharmaceuticals was born from a bold vision by visionary entrepreneurs and seasoned scientists to reshape the pharmaceutical landscape. With a focus on innovation, quality, and ethical partnerships, APDM quickly established ourselves as a dynamic industry force.

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