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Analytical Services

Analytical Services

We offer a full range of analytical services, including analytical method development, validation and transfer, stability studies, comparator and in-process testing, from our state-of-the-art facilities and experienced scientific staff.

Our Analytical capabilities

  • Pre-formulation
    • Solubility
    • Forced degradation
    • Particle size
    • Excipient Compatibility
    • Fast content uniformity
  • Analytical Methods Development / Validation / Transfer
  • Clinical Supply Release
  • Stability studies
  • API Chemical properties:
    • Solubility (equilibrium / kinetic), hygroscopicity, thermal behaviour, log P, stability.
  • API Physical properties:
    • Microscopy, particle size
  • Identification of unknown impurities
  • Cleaning validations
  • Comparator Testing
    • Fixed Dose Combination, Modified Release formulations
  • In-process testing
    • Blend Uniformity
    • Hardness / Friability / Bulk Density
    • Disintegration
    • Moisture (KF and LOD)
    • Particle size distribution (granules)
    • Sieve fraction analysis
  • Analysis to Support Formulation Development
    • Excipient Compatibility
    • Fast content uniformity
    • Bio-relevant Dissolution for formulation selection
    • Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients
  • Analytical (Microbiology)
    • Environment Monitoring of Classified Areas.
    • Microbiological analysis of Water. (Testing the quality of water)
    • Microbial Enumeration Test (Total number of microorganism present in product ).
    • All testing as GLP requirements.
    • Stability Studies along with Preservative Efficacy testing

Sites

  • Ahmedabad, India
  • Mumbai, India
  • Morpeth, UK
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