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For more than two decades, we are providing comprehensive pharmaceutical analytical services to clients across the industry. Our services include method verification, development and validation, impurity identification and characterizations and isolation of impurities by preparative scale purification, reverse phase/normal phase, ion-exchange or gel filtration chromatographic techniques. Our analytical team works in close collaboration with our process chemistry team to ensure that every method suits the process requirements for raw materials, APIs and formulations.

Our pharmaceutical analytical services research team is well versed with current regulatory requirements to support you from early research to market.

We offer method verification, development and validation for excipients, raw materials, APIs and drug products including high potent compounds, steroids, carbohydrates and synthetic peptides.

Our Custom Services also Include:

  • Purity of Enantiomers
  • Identification of related substances and assay
  • Method development for non-chromophoric compounds
  • Fate and purge studies
  • Genotoxic Impurity (GTI) studies
  • Impurity isolation and characterization
  • Assay, dissolution, content uniformity and impurities content studies

Analytical instruments

  • HPLC with VWD, DAD, ELSD, CAD and RID
  • UPLC with VWD and DAD
  • LC-MS/MS triple quard
  • GC and GC-HS
  • Ion Chromatography
  • AB Sciex QTRAP 4500 Mass Spec
  • NMR 400 MHz
  • Amino Acid Analyzer
  • Dissolution: USP type I and type II, small volume dissolutions using USP Type II apparatus and in-vitro diffusion cell apparatus
  • UV-VIS Spectrophotometer
  • FT-IR Spectrophotometer
  • Polarimeter
  • Auto-titrator and KF Apparatus
  • Differential Scanning Calorimeter
  • Thermo Gravimetric Analyser
  • Particle Size Analyser (Malvern)
  • Nano-particle Size Analyser (zeta sizer)

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research and manufacturing services

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