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500878 Vitamin E dry powder

Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP

Products

Catalogue NumberPackaging Qty/Pack
5008789024 Double PE Sack 20 kg
Description
Catalogue Number500878
References
Product Information
GradePh Eur,BP
HS Code2106 90 98
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
pH value7 (50 g/l, H₂O, 20 °C) (slurry)
Bulk density450 kg/m3
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 3 highly 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 +15°C to +25°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
all-rac-α-Tocopheryl acetate content (GC, Ph Eur)50.0 - 57.5 %
Identity (GC)passes test
As (Arsenic)≤ 0.0003 %
Cu (Copper)≤ 50 ppm
Pb (Lead)≤ 10 ppm
Zn (Zinc)≤ 25 ppm
Ethanol (HS-GC)≤ 5000 ppm
Acetic acid (HS-GC)≤ 5000 ppm
Heptane (HS-GC)≤ 5000 ppm
Methanol (HS-GC)≤ 3000 ppm
Pyridine (HS-GC)≤ 200 ppm
Toluene (HS-GC)≤ 890 ppm
Other residual solvents (ICH Q3C)excluded by production process
Loss on drying≤ 5.0 %
Total aerobic microbial count (TAMC)≤ 1000 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 (*).
Not for food use.
Corresponds to Ph Eur, BP
Global Trade Item Number
Catalogue Number GTIN
5008789024 04022536938851

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Vitamin E dry powder SDS

Title

Safety Data Sheet (SDS) 

Vitamin E dry powder Certificates of Analysis

Product Number PackagingSpecificationLot Number
5008789024 Double PE SackPDF Specification Document

Certificates

Title