• Analytical method development, validation and testing
    • HPLC (High Performance Liquid Chromatography)
    • Dissolution
    • IVRT (In Vitro Release Testing; using Vertical Diffusion cells, Franz Diffusion cells, or immersion cells)
    • UV-Vis Spectroscopy
    • FTIR (Fourier-transform Infrared Spectroscopy)
    • TLC (Thin-layer Chromatography)
    • Karl Fisher water content determination
  • Cleaning Validation Sample analysis
  • Process Validation Sample analysis
  • Batch/lot release testing for Active Pharmaceutical Ingredients (APIs) and formulated drug products
  • Preclinical dosage strength confirmation
  • Stability testing (to support formulation development, preclinical, clinical and ANDA activities)
  • USP testing

Since its inception, Tergus Pharma has been providing analytical expertise and laboratory services for analytical method development, validation and testing for topical and specialty dosage form products. Analytical method development, validation and testing can be provided for a variety of dosage forms including:

Topical Dosage Forms

  • Creams
  • Ointments
  • Lotions
  • Liquids
  • Suspensions
  • Gels
  • Hydrogels
  • Pastes
  • Pump Sprays
  • Topical Aerosols
  • Foams
  • Microencapsulation
  • Liposomes/Ethosomes
  • Suppositories
  • Nail Lacquers

Oral Dosage Forms

  • Tablets
  • Capsules
  • Fast dissolving tablets
  • Polymer gels
  • Films

Alternative Dosage Forms

  • Ophthalmic suspensions
  • Suppositories
  • Buccal patches

 

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