Raw Material & Excipient Qualification

Overview

Raw Material and Excipient Testing to Pharmacopoeial Standards

In order to manufacture any pharmaceutical product, it is essential to establish the identity, purity and quality of its starting materials, in order to ensure that the final product exhibits desired therapeutic effects.

Tests

VIMTA tests drug raw materials and excipients routinely as per latest pharmacopoeial requirements (USP, BP, EP, IP, and JP), including the following tests

  • Identification tests
  • Trace metal analysis by using AAS and ICP-MS techniques
  • Organic volatile impurities and residual solvents as per USP
  • Heavy metals

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