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107654 Cukróza (sacharóza)

pre denzitnú gradientovú ultracentrifugáciu, vhodná pre biofarmaceutickú výrobu EMPROVE® EXPERT Ph.Eur.,BP,NF,JP

Cukróza (sacharóza) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Saccharose

CAS #: 57-50-1 EC Number: 200-334-9 Molar Mass: 342.30 g/mol Hill Formula: C₁₂H₂₂O₁₁ Grade: Ph.Eur.,BP,NF,JP
107654
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Overview

Replacement Information

Key Spec Table

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

Products

Catalogue NumberPackaging Qty/Pack
1076541000 Plastová flaša 1 kg
1076545000 Plastová flaša 5 kg
1076549029 Dvojité PE vrecko 25 kg
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 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
StorageNoTempLimit
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
Global Trade Item Number
Catalogue Number GTIN
1076541000 04022536093437
1076545000 04022536093451
1076549029 04027269246907

Documentation

Material Qualification Dossier

TitleVersion
4.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

Title

Cukróza (sacharóza) MSDS

Title

Safety Data Sheet (SDS) 

Cukróza (sacharóza) Certificates of Analysis

Product Number PackagingSpecificationLot Number
1076541000 Plastová flašaPDF Specification Document
1076545000 Plastová flašaPDF Specification Document
1076549029 Dvojité PE vreckoPDF Specification Document

Certificates

Title