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104078 Żelatyna

Przegląd

Replacement Information

Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1040781000 Butelka plastikowa 1 kg
1040789029 Podwójny worek PE 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 Szczur > 5000 mg/kg
Safety Information according to GHS
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKNWG nie odziaływuje na środowisko wodne
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +15°C do +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
Numer katalogowy GTIN
1040781000 04022536047218
1040789029 04022536938561

Documentation

Emprove Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Żelatyna MSDS

Title

Safety Data Sheet (SDS) 

Żelatyna Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1040781000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1040789029 Podwójny worek PEDokument ze specyfikacją, w formacie PDF

Certificates

Title