Manufacturing and Analytical Services

Kappa Chemistry offers a full range of Vitamin K2 MK-7 analytical services and Reference Standards in a full cGMP certified lab.


Kappa Chemistry Service Portfolio:

  • Analyses according to official monographs (PhEur, USP, AOCS)
  • Method development, implementation, optimization & validation
  • Long-term stability studies
  • Forced degradation studies
  • Impurity profiles
  • Structural Elucidation of Unknowns
  • Reference Standard Characterization
  • Solubility studies
  • Response factor studies
  • Batch control
  • Release analysis
  • Process support
  • Technology transfer to QA with contract manufacturing partners
  • QP - Qualified person service

The Kappa Chemistry laboratory is outfitted with state-of-the-art analysis equipment. Analytical capabilities range from the analysis of highly-pure substances and concentrated preparations to a variety of low concentration products. The available selection of instruments and equipment support a wide range of testing requirements, including GMP compliant testing, to ensure accurate and reliable results. Kappa uses qualified and calibrated laboratory equipment such as:

  • Agilent HPLC with secure Open Lab software for data traceability and audit trail
  • HPLC analysis with sensitive 60 mm detector flow cell, for low concentration samples
  • Qualified and calibrated analytical balances to ensure accurate weighing of low sample amounts
  • Qualified and calibrated climate cabinets for stability testing

Specialized Analytical Services:

  • Active Pharmaceutical Ingredients (API)/
  • Raw materials
  • Excipients
  • Solid formulations
    • Tablets (coated and uncoated)
    • Capsules (hard and soft gelatine capsules)
  • Liquid formulations (solutions, suspensions, injectables)
  • Semi-solid formulations (gels, creams, ointments, suppositories)

K2 MK-7 Reference Standards:

K2VITAL® Reference Standard is the only standard substance specifically available for the analysis of Vitamin K2 MK-7 in dietary supplements, nutraceutical raw materials and finished products. The Reference Standard is 100% pure vitamin K2 MK-7, and may be used for both quantity measurement and for cis/trans purity assessment. It is very well-characterized for identity and purity by NMR, IR, and HPLC, water content by Karl Fischer and residual solvent content by GC. Kappa became is the certified vendor to United States Pharmacopeia (USP) for the MK-7 Reference Standard.

Other for Manufacturing and Analytical Services:

  • Re-write and re-format IRA NutraChampion document as ‘History/Milestones of Kappa Chemistry’
  • Post Analytics Academy Paper (& Fact Sheet?)
  • Production Graphics/Molecule from Academy Papers
  • Production Video?

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Sales and Marketing
Kappa Ingredients GmbH
Deichstrasse 29 | 20459 Hamburg
Germany

Headquarter
Kappa Bioscience AS
Silurveien 2 | Building B | 0380 Oslo
Norway

+49 40 6094087 0