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104078 Gelatin

powder, EMPROVE® ESSENTIAL Ph Eur,BP,NF

Gelatin MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 9000-70-8 EC Number: 232-554-6 Grade: Ph Eur,BP,NF
104078
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberGrade Value
9000-70-8232-554-6Ph Eur,BP,NF

Products

Catalogue NumberPackaging Qty/Pack
1.04078.1000 Plastic bottle 1 kg
1.04078.9029 Double PE Sack 25 kg
Description
Catalogue Number104078
References
Product Information
CAS number9000-70-8
EC number232-554-6
GradePh Eur,BP,NF
HS Code3503 00 19
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
pH value3.8 - 7.6 (10 g/l, H₂O, 25 °C)
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 5000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKNWG not water endangering
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
Appearancefaintly yellow to light yellowish-brown granular powder
Identity (IR-spectrum)passes test
Identity (coloring)passes test
Identity (gelatinizing property)passes test
pH (10 g/l, CO₂-free water)3.8 - 7.6
Conductivity (1.0 %, 30 °C)≤ 1 mS/cm
Sulfur dioxide (SO₂)≤ 50 ppm
Al (Aluminium)≤ 5 ppm
Cr (Chromium)≤ 10 ppm
Fe (Iron)≤ 30 ppm
Zn (Zinc)≤ 30 ppm
Peroxide (as H₂O₂)≤ 10 ppm
Residual solvents (ICH (Q3C))excluded by manufacturing process
Bloom value (about 110)90 - 130
Loss on drying (105 °C, 16h)≤ 15.0 %
Total aerobic microbial count (TAMC)≤ 10³
Total combined yeasts/moulds count (TYMC)≤ 10²
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 the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.

Corresponds to the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.
Global Trade Item Number
Catalogue Number GTIN
1.04078.1000 04022536047218
1.04078.9029 04022536938561

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Gelatin SDS

Title

Safety Data Sheet (SDS) 

Gelatin Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.04078.1000 Plastic bottlePDF Specification Document
1.04078.9029 Double PE SackPDF Specification Document

Certificates

Title