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100892 Sacharóza

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
57-50-1200-334-9C₁₂H₂₂O₁₁342.30 g/molPh Eur,BP,ChP,JP,NF

Products

Catalogue NumberPackaging Qty/Pack
1008925000 Plastová flaša 5 kg
1008929013 Plastové vedro 12 kg
1008929029 Dvojité PE vrecko 25 kg
1008929050 Kartónová krabica 50 kg
Description
Catalogue Number100892
SynonymsSaccharose, Sugar beet
References
Product Information
CAS number57-50-1
EC number200-334-9
GradePh Eur,BP,ChP,JP,NF
Hill FormulaC₁₂H₂₂O₁₁
Molar Mass342.30 g/mol
HS Code1701 99 10
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.59 g/cm3 (25 °C)
Melting Point185.5 °C
pH value5.5 - 7.5 (342 g/l, H₂O, 25 °C)
Bulk density800 - 950 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan 29700 mg/kg
Safety Information according to GHS
RTECSWN6500000
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
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 +2°C až +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Identity (wet chemistry)passes test
Identity (IR)passes test
Appearance of solution (50 %; water)passes test
Color of solutionpasses test
Color number≤ 45
Spec. rotation (α 20/D; 26 %; water)66.3 - 67.0 °
Spec. rotation (α 20/D; 10 %; water)66.3 - 67.0 °
Electrical conductivity≤ 35 µS/cm
Sulfite (as SO₂)≤ 10 ppm
Sulfate (SO₄)≤ 0.05 %
Heavy metals (as Pb)≤ 0.0005 %
Ca (Calcium)≤ 0.05 %
Dextrinspasses test
Reducing sugarspasses test
Reducing sugars (ChP)≤ 0.10 %
Residual solvents (ICH Q3C)excluded by production process
Loss on Drying (105 °C)≤ 0.1 %
Sulfated ash≤ 0.1 %
Endotoxins≤ 2 I.U./g
Microbiological purity (Total aerobic microbial count (TAMC))≤ 500 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 100 CFU/g
Bile tolerant Gram negative Bacteria (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Salmonella ssp (absent in 10 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, ChP, JP, NF
Global Trade Item Number
Catalogue Number GTIN
1008925000 04027269143787
1008929013 04027269170561
1008929029 04022536987118
1008929050 04022536924960

Documentation

Material Qualification Dossier

TitleVersion
10.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sacharóza MSDS

Title

Safety Data Sheet (SDS) 

Sacharóza Certificates of Analysis

Product Number PackagingSpecificationLot Number
1008925000 Plastová flašaPDF Specification Document
1008929013 Plastové vedroPDF Specification Document
1008929029 Dvojité PE vreckoPDF Specification Document
1008929050 Kartónová krabicaPDF Specification Document

Certificates

Title

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Categories

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Binders and Fillers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers