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Fats and Oils – all tests including Omega-3 Fatty Acids Determination and Profile

Fats & Oils Testing

Complete USP <401> Profile Including Omega-3 zAnalysis

Overview Service

Capzer Pharmaceuticals provides comprehensive testing for pharmaceutical fats, fixed oils, and nutraceutical lipids used in capsules, creams, and emulsions. Our FDA/DEA-registered cGMP laboratory performs USP <401>, FCC, and client methods to verify identity, purity, peroxide value, and fatty acid composition for raw material release.

Core Tests Performed

Standard parameters ensure compliance across vegetable, animal, and marine oils.

  • Acid value, saponification value, iodine number, peroxide value (<10 meq/kg).

  • Unsaponifiable matter, specific gravity, refractive index, viscosity.

  • GC-FID fatty acid profiling (C4:0 to C24:1) with AOCS/USP methods.

Omega-3 Fatty Acids Determination

Quantitative GC analysis identifies EPA, DHA, ALA, and total omega-3 content per USP <401> Method III. Ethyl ester or triglyceride forms receive complete profiles with resolution of positional isomers, supporting nutraceutical claims and stability monitoring.

Key Capabilities

  • Identification: TLC per USP (corn/olive oil standards).
  • Oxidative stability: Anisidine value, TOTOX calculation.
  • Impurities: Phospholipids, heavy metals (ICP-MS), microbial limits.

Benefits for Partners

Partners obtain CoAs for lipid excipients in Gabapentin softgels and Empagliflozin formulations from our ISO 17025 facility, ensuring ANDA stability data and supply chain compliance.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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