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Drug Product Characterization Studies and Testing Services

Drug Product Characterization Studies and Testing Services

Extensive characterization capabilities to enable complete profiling of drug products of various complexities.

Our characterization services for NCEs, generics and first generics help assess the quality characteristics of drug products like physical and chemical properties, which are primary elements to ensure the desired quality, considering the safety and efficacy of the drug product. We help to understand physical, chemical and microbiological properties or characteristics that should be within an appropriate specification to ensure the desired product quality.

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Stages of Drug Product Analytical Services

  • Analytical support to early phase preformulation studies and product development
  • Analytical method development
  • Analytical method validation
  • Analytical method transfer
  • Stability analysis (developmental, clinical and registration batches)


  • Assay
  • Degradation products or Related substances or Impurities content
  • Dissolution
  • Chiral purity
  • Identification by UV/PDA/IR/TLC
  • Polymorphic form identification
  • Preservative content
  • Antioxidant content
  • Content Uniformity
  • Water content by KF
  • Loss on Drying
  • Viscosity
  • Acid Neutralizing capacity
  • Particulate matter (visual and sub-visible)
  • Residual solvents
  • Microbial Limit tests for the various microorganisms including BCC
  • Sterility and Bacterial Endotoxins Test (BET)
  • Antimicrobial Effectiveness Test (AET) / Preservative Efficacy Test (PET)
  • Elemental impurities
  • Nitrosamine impurities


  • HPLC with PDA, UV, MWD, ELSD, RI and CAD detectors
  • UPLC
  • Dissolution apparatus
  • Small volume dissoluiton apparatus
  • Stability chambers including photostability chamber
  • Franz diffusion cell
  • UV-visible spectrophotometer
  • GC with head-space
  • Micro, analytical and top load balances
  • Sonicator
  • Shaking water bath
  • Centrifuge
  • Rotary shaker
  • Water purification system
  • Refrigerators
  • Sophisticated instruments like NMR 400 MHz, ICP-MS, DSC, TGA and FT-IR
  • Ion chromatography
  • Viscometer
  • Amino acid analyser
  • Volumetric and coulometric KF Auto titrator
  • Particle size analyzer
  • Zetasizer
  • Preparative HPLC
  • Isolator

Analytical Services for Following Drug Products

  • Immediator delayed or sustained or controlled release tablets
  • Orally disintegrating tablets
  • Chewable tablets
  • Sublingual tablets
  • Mini tablets
  • Bilayered tablets
  • Floating drug delivery systems
  • Capsules (soft gelatin and hard gelatin)
  • Pellets
  • Conventional liquid injections
  • Lyophilized injection
  • Oral solutions
  • Creams
  • Ointments
  • Lotions

Extended Analytical Services

  • Only analytical method developments
  • Transferring the developed methods from customers and executing validation of the developed methods
  • Modifying the customer developed analytical methods to get in-house developed methods and executing their validations.
  • Transferring the validated methods from the customers through formal protocols to the manufacturing plants

Why Aurigene Pharmaceutical services?

Experience with various characterization techniques

Expertise and multi disciplinary skill set team

US FDA-inspected labs with advanced instrumentation

Understanding of various regulatory and pharmacopeial requirements

Specialized separate expertise team exist for handling advanced instruments

Phase appropriate analytical methods developed and validated

New generation digitaIized tools exist for the execution of all analytical activities

Dedicated project manager exist for driving the project mile stones

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