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103789 Sucrose

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
57-50-1200-334-9C₁₂H₂₂O₁₁342.30 g/molPh Eur,ChP,JP,NF
Description
Catalogue Number103789
SynonymsSaccharose, Saccharose, Sugar beet
References
Product Information
CAS number57-50-1
EC number200-334-9
GradePh Eur,ChP,JP,NF
Hill FormulaC₁₂H₂₂O₁₁
Molar Mass342.30 g/mol
HS Code1701 99 00
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
Safety Information according to GHS
RTECSWN6500000
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Transport Information
Supplemental Information
Specifications
Descriptionwhite crystalline powder
Identity 1 (ChP)passes test
Identity 2 (ChP)passes test
Identity (Ph. Eur., JP, NF)passes test
Appearance of solution (50 %; water)passes test
Color of solutionpasses test
Color number≤ 45
Spec. rotation (.a. 20/D;26% water)66.3 - 67.0 °
Conductivity (20 °C)≤ 35
Sulfate (SO₄)≤ 0.05 %
Sulfite (as SO₂)≤ 10 ppm
Ca (Calcium)≤ 0.05 %
Heavy metals (as Pb)≤ 0.0005 %
Residual solvents (ICHQ3C) of class 2 (Methanol)≤ 3000 ppm
Other residual solvents (ICH Q3C)excluded by manufacturing process
Dextrinspasses test
Reducing sugars (Ph. Eur., JP, NF)passes test
Reducing sugar (ChP)≤ 0.10
Residue on ignition (as sulfate)≤ 0.1
Loss on Drying (105 °C)≤ 0.1
Endotoxins< 0.3
Total aerobic microbial count≤ 10¹
Total yeast and mould count≤ 10¹
Salmonella spp.absent in 10 g
E.coliabsent in 1 g
Staphylococcus aureusabsent in 1 g
Pseudomonas aeruginosaabsent in 1 g
Candida albicansabsent in 1 g
Bile tolerante gram negative bacteriaabsent in 1 g
DNases (Exo- and endonucleases) (not detectable)passes test
RNases (not detectable)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.,ChP,JP,NF

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sucrose SDS

Title

Safety Data Sheet (SDS) 

Sucrose Certificates of Analysis

Product Number PackagingLot Number
103789

Certificates

Title

Technical Info

Title
Protecting Protein Stability with a Novel Grade of Sucrose