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

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Vitamin D₃ (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) 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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      		 Glass bottle 10 g
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      5009360100
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          		 Glass bottle 100 g
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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 SegmentMQ500
          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 °
          Methylformate (HS-GC)
          ≤ 1000 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.
          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

          Documentation

          Material Qualification Dossier

          TitleVersion
          10.0

          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

          Certificates

          Title