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501890 Vitamin K₁ (phytomenadione)

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaMolar MassGrade Value
84-80-0201-564-2C₃₁H₄₆O₂450.71 g/molPh Eur,BP,USP,FCC

Products

Catalog NumberPackaging Qty/Pack
5018900001 Glass bottle 1 g
5.01890.0100 Alu bottle 100 g
5018901003 Alu bottle 1 kg
Description
Catalogue Number501890
Synonyms2-Methyl-3-phytyl-1,4-naphthoquinone
References
Product Information
CAS number84-80-0
EC number201-564-2
GradePh Eur,BP,USP,FCC
Hill FormulaC₃₁H₄₆O₂
Molar Mass450.71 g/mol
HS Code2936 29 40
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Boiling point140 - 145 °C (0.0013 hPa)
Density0.984 g/cm3 (20 °C)
Melting Point-20 °C
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 33487 mg/kg
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +15°C to +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
Assay (HPLC, Ph Eur): trans-phytomenadione≥ 85.0 %
Assay (HPLC, Ph Eur): sum of trans-phytomenadione,cis-phytomenadione and trans-epoxyphytomenadione97.0 - 103.0 %
Assay (HPLC, USP)97.0 - 103.0 %
Identity (IR-spectrum)passes test
Identity (UV-absorption, Ph Eur)passes test
Identity (UV-absorption, USP)passes test
Identity (HPLC)passes test
Identity (optical rotation)passes test
Appearanceclear, yellow, viscous, oily liquid
Appearance of solution (100 g/l; trimethylpentane)clear
Neutral reactionpasses test
Refractive index (n 25/D)1.523 - 1.526
Optical rotation-0.05 - 0.05 °
As (Arsenic)≤ 3 ppm
Cu (Copper)≤ 25 ppm
Pb (Lead)≤ 2 ppm
Zn (Zinc)≤ 25 ppm
Related substances (HPLC, Ph Eur) (Impurity B)≤ 0.2 %
Related substances (HPLC, Ph Eur)(any unspecified impurities)≤ 0.15 %
Related substances (HPLC, Ph Eur) (Sum of all impurities)≤ 1.0 %
cis-phytomenadione (HPLC, USP)≤ 21.0 %
Menadione (USP)passes test
Menadione (TLC, Ph Eur)≤ 0.2 %
Acetone (HS-GC)≤ 500 ppm
ethyl ether (HS-GC)≤ 500 ppm
Methanol (HS-GC)≤ 300 ppm
Petroleum ether (HS-GC)≤ 290 ppm
Toluene (HS-GC)≤ 890 ppm
Other residual solvents (ICH Q3C)excluded by production process
Acid value≤ 2.0
Sulfated ash (600 °C)≤ 0.1 %
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph Eur, BP, USP, FCC
Global Trade Item Number
Catalog Number GTIN
5018900001 04022536258683
5.01890.0100 04022536258690
5018901003 04027269192716

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Vitamin K₁ (phytomenadione) SDS

Title

Safety Data Sheet (SDS) 

Vitamin K₁ (phytomenadione) Certificates of Analysis

Product Number PackagingSpecificationLot Number
5018900001 Glass bottlePDF Specification Document
5.01890.0100 Alu bottlePDF Specification Document
5018901003 Alu bottlePDF Specification Document

Certificates

Title

Technical Info

Title
5.01890 Change Notification Letter