Pharmaceutical & Life Sciences

Pharmacopoeial-grade reagents, qualified instruments and the documentation an inspector expects to see alongside them.

A pharmaceutical QC laboratory buys paperwork as much as it buys reagents. A pharmacopoeial grade is not a purity claim — it means the batch was tested against every test in a named monograph, and the Certificate of Analysis proves it. The same logic runs through the equipment: a GMP-specification autoclave differs from the standard model in its contact surfaces, its control system, its printed cycle records and its qualification documentation, and an auditor will ask for chamber mapping and recovery studies. We quote against that requirement rather than against the cheaper model, and we say when the cheaper model would in fact be sufficient.

Tests run here

  • Assay and related substances by HPLC
  • Dissolution and content uniformity
  • Loss on drying and water content by Karl Fischer
  • Microbial limit testing and sterility
  • Residual solvents by GC headspace
  • Stability studies under ICH conditions

Governed by

  • Indian Pharmacopoeia (IP)
  • Schedule M, Drugs and Cosmetics Rules 1945 (revised 2023)
  • ICH Q1A(R2) and Q1B stability guidelines
  • WHO GMP
  • 21 CFR Part 11 for electronic records
  • culture-media
  • buffers-and-media
  • biochemicals
  • cold-storage
  • weighing
  • chromatography
  • spectroscopy
  • physical-properties
  • molecular-biology
  • sample-preparation

What this sector draws on

Send us your test schedule for this laboratory.

We will map it to grades, pack sizes and instrument specifications, and flag anything that is over-specified for what you are actually measuring.