Analytical Chemistry




OUR ROBUST CAPABILITIES SUPPORT YOUR PROJECTS

  • Drug substances
  • Drug products
  • Various dosage forms

Irvine’s long-standing team is committed to providing expert and timely analytical chemistry support. We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing.

We specialize in handling drug substances, drug products, and nearly all dosage forms including tablets, capsules, semi-solids, parenterals, sterile, transdermal, and inhalation products. Our device specialists oversee routine chemical and functional testing of packaging (elastomers, glass, plastics) and component testing. We also assist with vendor and contract manufacturer qualification. These essential services are why Irvine has earned a solid reputation in the industry since 1988.

EXPANSIVE SERVICES

  • Dissolution
  • Disintegration
  • Total organic carbon (TOC)
  • Thermal analysis (TGA and DSC)
  • Mercury analysis
  • Moisture determination (Karl Fischer, direct
    titration and coulometric titration)
  • Water activity
  • Inorganic impurity profile
  • Container/Closure testing
  • Atomic absorption metry (flame AA and
    GFAA)
  • Friability and disintegration
  • Particle size distribution (laser diffraction)
  • Osmolality
  • Controlled substance testing
  • Melting point determination
  • Residual solvents
  • Organic volatile impurities
  • Viscosity determination (Brookfield
    and capillary tube viscometer)
  • Nitrogen analysis
  • Specific gravity
  • Limit test
  • Identification test
  • Amino acid profile
  • Impurities profile
  • Cleaning validation and verification
  • Anion and cation determination
  • Elemental analysis
  • Index of refraction
  • Full compendial testing for rubber
    stoppers, glass, and plastic containers
  • Optical rotation
  • Particulate matter
  • Fatty acid profile
  • Full amino acid profile analysis
  • Compendial method verification (Learn more)



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INSTRUMENTATION

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