Pharmacopoeial Monograph Testing

Overview

Pharmacopoeial Testing to USP, BP, EP, IP, and JP

Pharmacopoeial monographs set out quality standards for medicines, Active Pharmaceutical Ingredients (APIs), and excipients, along with the tests required to demonstrate that the defined criteria are met.

At VIMTA, we routinely analyse drug products and substances in line with the latest pharmacopoeias (USP, BP, EP, IP, JP) or customer-specified procedures and specifications. Our pharmaceutical testing laboratories are equipped with a full array of analytical instrumentation, and all methods are used only after due verification or validation.

Tests

We are equipped to perform the following tests.

  • Assay (label content)
  • Degradation (related substances)
  • Dissolution
  • Metals
  • Residual solvents
  • Average net contents
  • Uniformity of mass
  • Identification
  • Melting point
  • pH
  • Particle count
  • Particle size
  • Turbidity
  • Fill volume
  • Water content
  • Weight loss
  • Water activity
  • Osmolality
  • Description, appearance
  • Product package interaction
  • Color of solution
  • Friability
  • Disintegration
  • Loss on drying
  • Viscosity
  • Weight / ml, density
  • Hardness, thickness, diameter
  • Resuspendability / sedimentation

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