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Our Services

Analytical Development

Stability-indicating methods, validation and impurity profiling to ICH guidelines.

Analytical Development

Service Overview

Analytical Development

Our analytical scientists develop, validate and transfer reliable, stability-indicating methods that support every stage of development — from early characterisation to release and stability testing. All work is carried out in line with ICH guidelines and documented for regulatory submission.

Our Capabilities

  • Method development (HPLC, UPLC, GC, UV)
  • Method validation as per ICH Q2
  • Impurity and degradation product profiling
  • Dissolution method development
  • Comparative dissolution profiling
  • Residual solvent and elemental impurity assessment
  • Reference standard characterisation
  • Analytical method transfer

Key Outcomes

  • Validated, stability-indicating methods
  • Reliable release and stability data
  • Regulatory-compliant documentation
  • Faster method transfer to QC laboratories

Let’s Accelerate Your
Drug Product Development Journey

Partner with Axenza Pharma for reliable, efficient, and customized pharmaceutical R&D solutions.

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