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104078 Želatína

Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
1040781000 Plastová flaša 1 kg
1040789029 Dvojité PE vrecko 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 Potkan > 5000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKNWG neohrozuje vodné prostredie
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 +15°C až +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
1040781000 04022536047218
1040789029 04022536938561

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Želatína MSDS

Title

Safety Data Sheet (SDS) 

Želatína Certificates of Analysis

Product Number PackagingSpecificationLot Number
1040781000 Plastová flašaPDF Specification Document
1040789029 Dvojité PE vreckoPDF Specification Document

Certificates

Title