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500859 Vitamín E, suchý prášok

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Vitamín E, suchý prášok MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
Grade: Ph Eur,BP,USP
500859
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,USP

Products

Catalogue NumberPackaging Qty/Pack
5008592500 Plastová flaša 2.5 kg
5008599029 Dvojité PE vrecko 25 kg
Description
Catalogue Number500859
References
Product Information
GradePh Eur,BP,USP
HS Code2106 90 90
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
pH value7 (50 g/l, H₂O, 20 °C) (kaša)
Bulk density360 kg/m3
Dimensions
Materials Information
Toxicological Information
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 +2°C až +25°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
all-rac-α-Tocopheryl acetate content (GC, Ph Eur)50.0 - 57.5 %
all-rac-α-Tocopheryl acetate content (GC, USP)49.0 - 57.5 %
Identity (TLC)conforms
Identity (GC)passes test
Identity (wet chemistry)passes test
Identity (optical rotation)passes test
Optical rotation α 25/D (all-rac-α-Tocopheryl acetate)-0.01 - 0.01 °
Heptane (HS-GC)≤ 5000 ppm
Methanol (HS-GC)≤ 3000 ppm
Other residual solvents (ICH Q3C)excluded by production process
Loss on drying (130 °C, vacuum, 4 h)≤ 5.0 %
Total aerobic microbial count (TAMC)≤ 100 CFU/g
Total combined yeasts/moulds count (TYMC)≤ 100 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Salmonella (absent in 10 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
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.
1 g of Vitamin E dry powder = 227,5 mg of α-Tocopherol equivalent (USP)
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
5008592500 04022536257037
5008599029 04022536938844

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Vitamín E, suchý prášok MSDS

Title

Safety Data Sheet (SDS) 

Vitamín E, suchý prášok Certificates of Analysis

Product Number PackagingSpecificationLot Number
5008592500 Plastová flašaPDF Specification Document
5008599029 Dvojité PE vreckoPDF Specification Document

Certificates

Title