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500936 SAFCVitamín D₃ (cholekalciferol)

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Vitamín D₃ (cholekalciferol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Material Qualification Dossier
Quality Management Dossier (Open Access)
Complete Dossier Part 2
SDS
CoA
Certificates

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

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Overview

Replacement Information

Key Spec Table

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

Products

Catalogue Number	Packaging	Qty/Pack
5009360010	Sklená flaša	10 g	Add To Favorites Add To Favorites Added To My Favorites
5009360100	Sklená flaša	100 g	Add To Favorites Add To Favorites Added To My Favorites

Description
Catalogue Number	500936
Synonyms	Colecalciferol, Cholecalciferol

References

Product Information
CAS number	67-97-0
EC index number	603-180-00-4
EC number	200-673-2
Grade	Ph Eur,BP,USP
Hill Formula	C₂₇H₄₄O
Molar Mass	384.65 g/mol
HS Code	2936 29 21
Structure formula Image
Quality Level	MQ500

Applications

Biological Information

Physicochemical Information
Melting Point	84 - 85 °C
Solubility	<0.1 g/l

Dimensions

Materials Information

Toxicological Information
LD 50 oral	LD50 Potkan 5 - 50 mg/kg
LD 50 dermal	LD50 Potkan 61 mg/kg

Safety Information according to GHS
Hazard Pictogram(s)
Hazard Statement(s)	H300 + H310 + H330: Pri požití, pri styku s kožou alebo pri vdýchnutí môže spôsobiť smrť. H372: Spôsobuje poškodenie orgánov pri dlhšej alebo opakovanej expozícii požitím.
Precautionary Statement(s)	P260: Nevdychujte prach. P262: Zabráňte kontaktu s očami, pokožkou alebo odevom. P280: Noste ochranné rukavice/ ochranný odev. P302 + P352 + P310: PRI KONTAKTE S POKOŽKOU: Umyte veľkým množstvom vody. Okamžite volajte TOXIKOLOGICKÉ INFORMAČNÉ CENTRUM/lekára. P304 + P340 + P310: PO VDÝCHNUTÍ: Presuňte osobu na čerstvý vzduch a umožnite jej pohodlne dýchať. Okamžite volajte TOXIKOLOGICKÉ INFORMAČNÉ CENTRUM/lekára. P314: Ak pociťujete zdravotné problémy, vyhľadajte lekársku pomoc/ starostlivosť.
Signal Word	Nebezpečenstvo
RTECS	VS2900000
Storage class	6.1A Horľavé, akútne toxické v kategóriach 1 a 2 / veľmi toxické nebezpečné látky
WGK	WGK 2 významne ohrozuje vodné zdroje
Disposal	9 Karcinogénne zlúčeniny a horľavé zlúčeniny označené ako "veľmi jedovaté" alebo "jedovaté": nádoba F. Alkylsulfáty sú karcinogénne. Buďte osobitne opatrní, aby nedošlo k vdýchnutiu alebo ku kontaktu s pokožkou. Alkylsulfáty neutralizujte pridaním (z oddeľovacieho lievika) koncentrovaného ľadového roztoku amoniaku (kat. č. 105426) po kvapkách za intenzívneho miešania. Pred vyliatím do nádoby D skontrolujte pH pomocou indikátorových prúžkov pH-Universal (kat. č. 109535).

Safety Information
Categories of danger	ve?mi jedovatá

Product Usage Statements

Storage and Shipping Information
Storage	Skladujte pri +2°C až +8°C.

Packaging Information

Transport Information
Declaration (railroad and road) ADR, RID	UN 2811 , 6.1, I
Declaration (transport by air) IATA-DGR	UN 2811 , 6.1, I
Declaration (transport by sea) IMDG-Code	UN 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

Documentation

Material Qualification Dossier

Title	Version
Material Qualification Dossier	8.0

Quality Management Dossier (Open Access)

Title
Quality Management Dossier

Operational Excellence Dossier

Title
Operational Excellence Dossier

Vitamín D₃ (cholekalciferol) MSDS

Title
Safety Data Sheet (SDS)

Vitamín D₃ (cholekalciferol) Certificates of Analysis

Product Number	Packaging	Specification	Lot Number
5009360010	Sklená flaša	PDF Specification Document	Enter Lot Number
5009360100	Sklená flaša	PDF Specification Document	Enter Lot Number

Certificates

Title
Aflatoxin Certificate for 500936 Vitamin D3 (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) EMPROVE® ESSENTIAL Ph Eur,BP,USP
BSE/TSE Certificate for 500936 Vitamin D3 (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) EMPROVE® ESSENTIAL Ph Eur,BP,USP
GMO Certificate for 500936 Vitamin D3 (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) EMPROVE® ESSENTIAL Ph Eur,BP,USP
Halal Certificate for 500936 Vitamin D3 (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) EMPROVE® ESSENTIAL Ph Eur,BP,USP
Kosher Certificate for 500936 Vitamin D3 (cholecalciferol) cryst. (1 g = 40 Mio.I.U.) EMPROVE® ESSENTIAL Ph Eur,BP,USP

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