Pharmacopoeial Monograph Testing

The Pharmacopoeial Monographs consists of thousands of quality standards for medicines, Active Pharmaceutical Ingredients (API) and excipients, along with describing various tests in order to validate that the defined criteria are met.

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