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500859 Vitamin E dry powder (50 g all-rac-α-tocopheryl acetate in 100 g substance)

EMPROVE® ESSENTIAL Ph Eur,BP,USP

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 Plastic bottle 2.5 kg
5008599029 Double PE Sack 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) (slurry)
Bulk density360 kg/m3
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +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

Vitamin E dry powder (50 g all-rac-α-tocopheryl acetate in 100 g substance) SDS

Title

Safety Data Sheet (SDS) 

Vitamin E dry powder (50 g all-rac-α-tocopheryl acetate in 100 g substance) Certificates of Analysis

Product Number PackagingSpecificationLot Number
5008592500 Plastic bottlePDF Specification Document
5008599029 Double PE SackPDF Specification Document

Certificates

Title