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501890 Vitamin K₁ (phytomenadione)

Overview

Replacement Information

Key Spec Table

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

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5018900100
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      Alu bottle 100 g
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      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
      Catalogue Number GTIN
      5018900100 04022536258690

      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
      5018900100 Alu bottlePDF Specification Document

      Certificates

      Title