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500936 Vitamin D₃（維生素D3）結晶(1 g = 40 Mio.I.U.)

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Vitamin D₃（維生素D3）結晶(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

Products

Catalogue NumberPackaging Qty/Pack
5.00936.0010 玻璃瓶 10 g
5.00936.0100 玻璃瓶 100 g
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
5.00936.0010 04022536257310
5.00936.0100 04022536257327

Documentation

Material Qualification Dossier

TitleVersion
8.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Title

Vitamin D₃（維生素D3）結晶(1 g = 40 Mio.I.U.) MSDS

Title

Safety Data Sheet (SDS) 

Vitamin D₃（維生素D3）結晶(1 g = 40 Mio.I.U.) Certificates of Analysis

Product Number PackagingSpecificationLot Number
5.00936.0010 玻璃瓶PDF Specification Document
5.00936.0100 玻璃瓶PDF Specification Document

Certificates

Title