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cGMP-certified Laboratory Analysis

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All of Equateq's production is supported by cGMP-certified analyses at our dedicated lipid laboratory.

 

The analytical facility has passed an FDA pre-approval inspection and MHRA inspections and performs analyses in compliance with cGMP standards for Active Pharmaceutical Ingredients and Drug Products for both Investigational Medicinal Products and licensed products.

 

Equateq also offer a comprehensive stability testing service using our continuously monitored, temperature and humidity controlled cabinets, with storage conditions ranging from -20C to 40C/75%RH in accordance with ICH guidelines.

 

Every aspect of stability testing is catered for, from advice on study design, evaluation of stability indicating parameters/methods and method validation, to provision of a comprehensive final report.

 

a3.jpg Our analytical expertise is primarily with edible oils and the analyses we currently offer include:

 

  • Acid value
  • Peroxide value
  • p-Anisidine value
  • Iodine value
  • Moisture content (Karl Fisher)
  • Saponification value
  • Unsaponifiable matter
  • Fatty acid profile by GC-FID
  • Quantitative fatty acids; GLA, EPA, DHA, DPA, etc
  • Residual solvents by GC-Headspace
  • Tocopherol analysis - HPLC
  • Conjugated dienes
  • Lovibond & Gardner colour
  • Heavy metals
  • Residue on ignition
  • Vitamin A and D
  • B-carotene
  • Chlorophyll
  • Capsule disintegration
  • Capsule Fill Weight/Uniformity

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A range of other analyses are also possible -- please ask.

 

The equipment which we use includes:

 

  • HPLC
  • Gas chromatography
  • Headspace GC
  • UV/visible spectrophotomtry
  • Fourier transform infra red spectrometry (FT-IR)
  • Atomic absorption