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107654 Sucrose (saccharose)

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
57-50-1200-334-9C₁₂H₂₂O₁₁342.30 g/molPh.Eur.,BP,NF,JP
Description
Catalogue Number107654
SynonymsSaccharose
References
Product Information
CAS number57-50-1
EC number200-334-9
GradePh.Eur.,BP,NF,JP
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 Rat 29700 mg/kg
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 (IR-spectrum)passes test
Appearance of solution (50 %; water)passes test
Color number≤ 45
Spec. rotation (.a. 20/D;26% water)+66.3 - +67.0 °
Conductivity (20 °C)≤ 35
Sulfite (as SO₂)≤ 10 ppm
Dextrinspasses test
Reducing sugarspasses test
Residual solvents (ICH Q3C) class 3 (Ethanol)≤ 0.5 %
Other residual solvents (ICH Q3C)excluded by manufacturing process
Loss on Drying (105 °C)≤ 0.1
Endotoxins< 0.25
Absorbance (260 nm; 50 %; 1 cm; water)≤ 0.07
Absorbance (280 nm; 50 %; 1 cm; water)≤ 0.05
Colony count (aerobic bacteria (TAMC))≤ 10²
Colony count (Yeasts and moulds (TYMC))≤ 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 detected
Proteasesnot detected
RNasesnot detected
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,JP,NF

Documentation

Material Qualification Dossier

TitleVersion
6.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Sucrose (saccharose) SDS

Title

Safety Data Sheet (SDS) 

Sucrose (saccharose) Certificates of Analysis

Product Number PackagingLot Number
107654

Certificates

Title

User Guides

Title
Raw Materials for Biopharmaceutical Manufacturing