Laboratory Services


Analytical Testing

  • Batch Level Release Testing
  • Heparin Potency
  • Complaint / Investigations Testing
  • Third Party Confirmation Testing
  • R&D Stability Testing
  • Identification Testing
  • Moisture Determinations
  • Water Vapor Transmission Testing
  • Melting Point Determinations
  • Specific Gravity Determination
  • Osmolality Determinations
  • Optical Rotation Determinations
  • FTIR Identification Testing
  • Heavy Metals by ICP-OES
  • UV / Vis Spectroscopy
  • Color Determinations via Hunterlab
  • Globule Size Analysis
  • Particulate Matter Determinations
  • BET Testing
  • Validated Test Method Licensing

Analytical Development and Validation Services

  • Stability Indicating Assay
  • Related Substances / Impurities
  • Preformulation Support Testing
  • Residual Solvent Analyses
  • Remedial Validation
  • Gap Analysis
  • Process Validation Support
  • Method Transfer Support
  • Formulation Development Support
  • Comparative Studies
  • Forced Degradation Studies
  • Light Stressing of Sample per ICH

R&D

  • Assistance in Proposing Drug Product Specifications
  • Container Closure Selection and Evaluation
  • Compatibility Studies
  • ICH Compliant Stability Studies
  • CMC Support

Rapid Sterility and BET Testing

  • Microbial Identification Testing
  • Sterility Testing
  • Endotoxin Testing


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