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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

Pricing & Availability

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5018900001
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      Glass bottle 1 g
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      5.01890.0100
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          Alu bottle 100 g
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          5018901003
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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
              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