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501890 Vitamín K₁ (fytomenadión)

Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
5018900001 Sklená flaša 1 g
5018900100 Hliníková flaša 100 g
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 Potkan > 33487 mg/kg
Safety Information according to GHS
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +15°C až +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
5018900001 04022536258683
5018900100 04022536258690

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Vitamín K₁ (fytomenadión) MSDS

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Safety Data Sheet (SDS) 

Vitamín K₁ (fytomenadión) Certificates of Analysis

Product Number PackagingSpecificationLot Number
5018900001 Sklená flašaPDF Specification Document
5018900100 Hliníková flašaPDF Specification Document

Certificates

Title