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BioPlus Life Sciences Pvt Ltd. Stabilized Vitamin K2

Stabilized Vitamin K2 is a unique formulation of double encapsulated Vitamin K2, an all-trans MK-7, identical to natural K2 active, fully bioactive providing best benefits for bones, heart and body.

Ingredient Name: Menaquinone-7

Functions: Vitamin Source

Labeling Claims: Halal, Kosher

Certifications & Compliance: BRC Certified, GMP, Halal, ISO 14001, ISO 22000, Kosher, NSF Approved, National Formulary (NF), SEDEX Approved, United States Pharmacopeia (USP)

Benefit Claims (Health): Improves Bone Health

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Identification & Functionality

Ingredient Name
Food Ingredients Functions
Pharma & Nutraceuticals Functions

Features & Benefits

Benefit Claims (Health)
Labeling Claims
Food Ingredients Features

Properties

Physical Form
Appearance
White to light yellow fine powder
Odor
Characteristic
Insoluble in
Water, Alcohol
Typical Properties
ValueUnitsTest Method / Conditions
Assay90 - 120%USP43-NF38, HPLC
Isomeric Purity (cis-menaquinone-7)max. 2.0%USP43-NF38
Limit of Menaquinone -6max. 10%USP43-NF38
Loss on Dryingmax. 5.0%Ph.Eur 2.2.32
pH5.5 - 8.0USP<791>
Residue on Ignitionmax. 0.2%USP43-NF38
Specific Gravity1.44g/cm³USP<841>
Tapped Bulk Density0.4 - 0.7g/cm³Ph.Eur 2.9.34
Trans K2 MK7min. 2000ppmUSP43-NF38
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliAbsent/gUSP43-NF38/Ph.Eur 10.4
SalmonellaAbsent/25gUSP43-NF38/Ph.Eur 10.4
Staphylococcus aureusAbsent/gUSP43-NF38/Ph.Eur 10.4
Total Viable Countmax. 1000cfu/gUSP43-NF38/Ph.Eur 10.4
Total Yeasts & Mould Countmax. 100cfu/gUSP43-NF38/Ph.Eur 10.4
Nutritional Information
ValueUnitsTest Method / Conditions
Carbohydrates91.96g/100g
Energy377.71kcal/100g
Fat2.24g/100g
Fibre1.49g/100g
Protein0.51g/100g
Composition
ValueUnitsTest Method / Conditions
Butylated Hydroxy Anisole0.1% w/w
Butylated Hydroxy Toluene0.1% w/w
Ethyl Cellulose7.0% w/w
Glycerol Dibehenate2.8% w/w
Vitamin K290.0% w/w
Residual Solvents
ValueUnitsTest Method / Conditions
Dichloromethanemax. 600ppmUSP<467>
Isopropyl Alcoholmax. 5000ppmUSP<467>
Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 2.0μg/gUSP43-NF38/ Ph.Eur 2.2.58/ Ph.Eur2.2.57
Cadmiummax. 1.0μg/gUSP43-NF38/ Ph.Eur 2.2.58/ Ph.Eur2.2.57
Leadmax. 3.0μg/gUSP43-NF38/ Ph.Eur 2.2.58/ Ph.Eur2.2.57
Mercurymax. 0.1μg/gUSP43-NF38/ Ph.Eur 2.2.58/ Ph.Eur2.2.57
Sieve Test
ValueUnitsTest Method / Conditions
Sieve Analysis (Passing through 100 mesh)min. 20%USP<786>
Sieve Analysis (Passing through 20 mesh)min. 99.5%USP<786>
Sieve Analysis (Passing through 40 mesh)min. 85%USP<786>
Identification by Thin Layer Chromatography

Limits : Under Visible light and short wavelength UV light, the spots from the sample solution correspond in color, shape and Rf value to those from the standard solution, under white light, correspond in color (dark blue), shape & Rf value to those from the standard solution.

Test Method : USP43-NF38

Identification by HPLC

Limits : The retention time of the major peak of the sample solution corresponds to that of the standards solution, as obtained in the test for content of Menaquinone -7.

Test Method : USP43-NF38

Regulatory & Compliance

Packaging & Availability

Packaging Type
Packaging

1kg or 5kg or 25kg in aluminum foil bags.

Storage & Handling

Shelf Life
2 Years
Storage Condition

Room temperature (15 - 30°C), protected from light, excessive heat & moisture in unopened original bags. If opened use within 60days or use entire upon opening.