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Services

Broadly, the areas in which Pharmaffiliates offer services are:

  • Analysis of pharmaceutical drug substances, drug products and raw materials
  • Custom Synthesis
  • Impurity synthesis
  • Impurity profiling
  • Structure elucidation
  • Polymorphism studies
  • Analytical Method Development
  • Method Validation & Transfer
  • Stability studies & Evaluation
  • Regulatory affairs
  • Quality Management
  • Dossier preparation
  • Submission and Approvals from the Regulatory Authorities worldwide
  • GMP Training
  •  Auditing
  • Marketing Support to SMEs.

Analysis of pharmaceutical drug substances, drug productsand raw materials

Testing of APIs, Drug product, raw materials and excepients is a necessary requirement in providing quality assurance to clients and ensuring the safety of end users.

Pharmaffiliates operate on a global basis and provide different tests using a diverse range of analytical techniques. Pharmaffiliates analytical testing laboratory network offers comprehensive analytical testing capabilities and techniques. Analytical laboratory techniques include:

  • Chemical Analysis
  • Identification (by HPLC,UV,IR,TLC etc)
  • Chromatographic Purity (by HPLC,GC,TLC)
  • Related substances (by HPLC,GC,TLC)
  • Vitamin by HPL
  • Content uniformity (by HPLC,UV,Titration)
  • Residual solvent/OVI by GC-head space
  • Dissolution profile
  • Dissolution test
  • Assay % w/w
  • Limit test
  • Friability test
  • Disintegration time
  • Microbial analysis

 

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