Kappa Bioscience
Analytics

Industry Leadership: Analytical Materials and Methods

Vitamin K2 formulation analysis for quality control and insight into product characteristics


Industry Leadership: Analytical Materials and Methods - Quality & Safety

See what CEO Egil Greve from Kappa Bioscience has to say about K2.


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In 2015 Kappa became a certified vendor to United States Pharmacopeia (USP)

When establishing the MK-7 monograph, USP chose Kappa Bioscience as supplier of the reference standard, due to the superior quality of Kappa‘s vitamin K2 MK-7 reference standard.

Kappa is also involved with the USP with regards to method development, the molecule characterization program and other aspects related to the development of various monographs, including vitamin K2 MK-7.

In 2016 Kappa Bioscience was requested to head a working group established by the AOAC INTERNATIONAL for development of official analytical methods for vitamin K1 and K2

The working group was launched as part of a broader program at the behest of the US National Institute for Health. AOAC’s primary activity is the development of globally accepted standards. AOAC’s standards development process relies on stakeholder panels to develop consensus-based method performance requirements, and volunteer expert review panels to evaluate potential methods – all based on the community’s specific method needs. AOAC® Official MethodsSM are published in the Official Methods of Analysis of AOAC INTERNATIONAL, and supporting manuscripts are published in the Journal of AOAC INTERNATIONAL. The resulting methodology, based on the workgroup and inclusive of testing of purity, assay and cis / trans configuration, will be ready for the market in the second half of 2017.

Supplier of the superior MK-7 reference standard

Kappa Chemistry has long, deep experience in the manufacture and delivery of reference standards. In pursuit of the overall development and advancement of the vitamin K2 industry, the decision was made to make available Kappa‘s superior-quality MK-7 reference standard through an industry-wide MK-7 quality program. This development led to Kappa‘s listing as the USP qualified vendor of reference standards for vitamin K2 MK-7 in their monograph developments.

 

K2VITAL® Reference Standard is the only standard substance specifically available for analysis of Vitamin K2 MK-7 in dietary supplements, nutraceutical raw materials and finished products. It is a standard that can be used not only for the quantity but also for the cis/trans purity assessment of products. The reference standard is 100% pure vitamin K2 MK-7. 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.

 

K2VITAL® Reference Standard is essential for any company using Vitamin K2 MK-7 for consumer applications and for companies that provide analytical services. As a primary grade reference standard, the K2VITAL® standard is used in relation to vitamin K2 MK-7 for:

Vitamin K2 formulation analysis for quality control and insight into product characteristics

Kappa Chemistry provides testing and formulation analysis for vitamin K2 on a wide range of products and formulations. The Kappa Chemistry laboratory is outfitted with state-of-the-art equipment to analyze and evaluate vitamin K2.

Kappa only 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

Analytical services include:

  • 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)

Analytical methods for K2 determination

Kappa Chemistry offers both inhouse developed methodologies and methods conducted in accordance with the U.S. Pharmacopeia for the analysis of K2. 

The USP 38 monograph describes a K2 analytical methodology for a variety of parameters including the identification, content/ assay, and testing for impurities and enantiomeric purity for: 

  • Pure Menaquinone-7 
  • Menaquinone-7 solid and liquid preparations 
  • Capsules 
  • Tablets 

Kappa Chemistry also developed a validated methodology for theassay of encapsulated MK-7 preparations and encapsulated MK-7 finished products (primarily products that contain minerals such as calcium or magnesium where microencapsulation promotes K2 stability). This methodology was submitted to USP in 2016 and is under evaluation for monograph release.

  • Recommended Laboratories
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  • Tutorial: Quality & Safety
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