Analytical Services for APIs in Support of Micronization and GMP Compliance

Munit integrates analytical services within its API micronization workflows to ensure every batch meets quality, consistency, and regulatory expectations. From method development to PSD control, we offer full analytical coverage under GMP.

What We Analyze

We perform analytical testing for:

  • Particle size distribution (PSD)
  • Moisture content
  • Residual solvents
  • Bulk/tap density and flowability
  • Visual appearance and morphology

Each method is validated per ICH Q2 guidelines and can be transferred or developed in-house.

Support for Development and Regulatory Submissions

Our analytical services support:

  • New product development
  • QbD/DoE studies
  • Clinical and commercial release
  • Regulatory documentation and audits

All data is backed by QA-reviewed protocols and reports.

Ensure your API meets quality specs at every stage.
Work with Munit’s analytical specialists.