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500936 Vitamin D₃ (cholecalciferol) cryst. (1 g = 40 Mio.I.U.)

EMPROVE® ESSENTIAL Ph Eur,BP,USP

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Colecalciferol, Cholecalciferol

CAS #: 67-97-0 EC Number: 200-673-2 Molar Mass: 384.65 g/mol Hill Formula: C₂₇H₄₄O Grade: Ph Eur,BP,USP
500936
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
67-97-0200-673-2C₂₇H₄₄O384.65 g/molPh Eur,BP,USP

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      5009360100
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          CO1E5009360010
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              CO1E5009360100
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                  Description
                  Catalogue Number500936
                  SynonymsColecalciferol, Cholecalciferol
                  References
                  Product Information
                  CAS number67-97-0
                  EC index number603-180-00-4
                  EC number200-673-2
                  GradePh Eur,BP,USP
                  Hill FormulaC₂₇H₄₄O
                  Molar Mass384.65 g/mol
                  HS Code2936 29 21
                  Structure formula ImageStructure formula Image
                  Quality LevelMQ500
                  Applications
                  Biological Information
                  Physicochemical Information
                  Melting Point84 - 85 °C
                  Solubility<0.1 g/l
                  Dimensions
                  Materials Information
                  Toxicological Information
                  LD 50 oralLD50 Rat 5 - 50 mg/kg
                  LD 50 dermalLD50 Rat 61 mg/kg
                  Safety Information according to GHS
                  Hazard Pictogram(s) Hazard Pictogram(s)
                  Hazard Pictogram(s)
                  Hazard Statement(s)H300 + H310 + H330: Fatal if swallowed, in contact with skin or if inhaled.
                  H372: Causes damage to organs through prolonged or repeated exposure if swallowed.
                  Precautionary Statement(s)P260: Do not breathe dust.
                  P262: Do not get in eyes, on skin, or on clothing.
                  P280: Wear protective gloves/ protective clothing.
                  P302 + P352 + P310: IF ON SKIN: Wash with plenty of water. Immediately call a POISON CENTER/doctor.
                  P304 + P340 + P310: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER/doctor.
                  P314: Get medical advice/ attention if you feel unwell.
                  Signal WordDanger
                  RTECSVS2900000
                  Storage class6.1A Combustible, acute toxic Cat. 1 and 2 / very toxic hazardous materials
                  WGKWGK 2 obviously hazardous to water
                  Disposal9
                  Carcinogenic compounds and flammable compounds labelled "Highly toxic" or "Toxic": container F. Alkyl sulfates are carcinogenic; Take particular care to avoid inhalation and skin contact. To neutralize alkyl sulfates, add dropwise (from a dropping funnel) to concentrated ice-cool Ammonia solution (Cat.No. 105426) with vigorous stirring. Before placing in container D, check the pH with pH Universal indicator strips (Cat.No. 109535).
                  Safety Information
                  Categories of dangervery toxic
                  Product Usage Statements
                  Storage and Shipping Information
                  StorageStore at +2°C to +8°C.
                  Packaging Information
                  Transport Information
                  Declaration (railroad and road) ADR, RIDUN 2811 , 6.1, I
                  Declaration (transport by air) IATA-DGRUN 2811 , 6.1, I
                  Declaration (transport by sea) IMDG-CodeUN 2811 , 6.1, I
                  Supplemental Information
                  Specifications
                  Assay (HPLC)97.0 - 102.0 %
                  Identity (IR-spectrum)passes test
                  Identity (HPLC)passes test
                  Identity (UV-spectrum (USP))passes test
                  Spec. rotation [α²0/D (8 g/l; (aldehyde-free alcohol 96 %))+105 - +112 °
                  Spec. rotation [α²5/D (5 g/l; ethanol)+105 - +112 °
                  As (Arsenic)≤ 3 ppm
                  Cu (Copper)≤ 25 ppm
                  Pb (Lead)≤ 10 ppm
                  Zn (Zinc)≤ 25 ppm
                  Acetone (HS-GC)≤ 5000 ppm
                  Hexane (HS-GC)≤ 290 ppm
                  Methanol (HS-GC)≤ 3000 ppm
                  Methylformate (HS-GC)≤ 1000 ppm
                  Pyridine (HS-GC)≤ 200 ppm
                  Other residual solvents (ICH Q3C)excluded by production process
                  Related substances (HPLC) (trans-cholecalciferol)≤ 0.1 %
                  Related substances (HPLC) (largest unspecified impurity)≤ 0.10 %
                  Related substances (HPLC) (Sum of all impurities)≤ 1.0 %
                  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
                  Global Trade Item Number
                  Catalogue Number GTIN
                  5009360010 04022536257310
                  5009360100 04022536257327
                  CO1E5009360010 0
                  CO1E5009360100 0

                  Documentation

                  Material Qualification Dossier

                  TitleVersion
                  8.0

                  Quality Management Dossier (Open Access)

                  Title

                  Operational Excellence Dossier

                  Title

                  Vitamin D₃ (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) SDS

                  Title

                  Safety Data Sheet (SDS) 

                  Vitamin D₃ (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) Certificates of Analysis

                  Product Number PackagingSpecificationLot Number
                  5009360010 Glass bottlePDF Specification Document
                  5009360100 Glass bottlePDF Specification Document
                  CO1E5009360010 PDF Specification Document
                  CO1E5009360100 PDF Specification Document

                  Certificates

                  Title