RAW MATERIAL AND EXCIPIENT QUALIFICATION

  • Very high quality requirements determined by the various pharmacopoeias for Raw materials and excipients to meet intended use.
  • Challenging of ingredients mandatory right from product development through to commercial batch release. Widespread attention will be given from drug development stage, deteriorating of consideration could hamper ultimate drug quality, fail to meet specification.
  • Raw material and excipient testing services are performed as per USP/IP/BP/EP/JP and/or customer requirements.
  • Umed offer batch/lot release testing, as well as verification services and offer Identification, Assay, Physicochemical properties, Related substance, Water content, Residual solvents, Polymorphic quantification, Particle size distribution and Elemental (Q3D) determinations etc.

Raw Material and Excipient testing is performed on:

  • Raw Materials
  • Intermediates
  • Excipients
  • Key starting materials (KSM)
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