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137045 Laktóza monohydrát

prášok, vhodný pre biofarmaceutickú výrobu EMPROVE® EXPERT Ph Eur,BP,ChP,NF,JP

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

Synonyms: Milk sugar, Lactobiose

CAS #: 10039-26-6 EC Number: 200-559-2 Molar Mass: 360.32 g/mol Hill Formula: C₁₂H₂₂O₁₁ * H₂O Grade: Ph Eur,BP,ChP,NF,JP
137045
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
10039-26-6200-559-2C₁₂H₂₂O₁₁ * H₂O360.32 g/molPh Eur,BP,ChP,NF,JP

Products

Catalogue NumberPackaging Qty/Pack
1370455000 Plastová flaša 5 kg
1370459029 Dvojité PE vrecko 25 kg
Description
Catalogue Number137045
SynonymsMilk sugar, Lactobiose
References
Product Information
CAS number10039-26-6
EC number200-559-2
GradePh Eur,BP,ChP,NF,JP
Hill FormulaC₁₂H₂₂O₁₁ * H₂O
Molar Mass360.32 g/mol
HS Code1702 11 00
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Ignition temperature390 °C
Melting Point202 °C
pH value4.0 - 6.5 (100 g/l, H₂O, 20 °C)
Bulk density500 kg/m3
Solubility161 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Potkan > 10000 mg/kg
Safety Information according to GHS
RTECSOD9625000
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 2 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 +15°C až +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
Assay (HPLC) (calc. on anhydrous substance)98.0 - 102.0 %
Identity (IR)passes test
Identity (TLC)passes test
Identity (HPLC)passes test
Identity (water)passes test
Appearance of solution (10 %; water)passes test
Clarity and color of solutionpasses test
Acidity or alkalinitypasses test
Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance)+54.4 - +55.9 °
Heavy metals (as Pb)≤ 5 ppm
As (Arsenic)≤ 0.0002 %
Related substances (sum of all impurities) (HPLC)≤ 0.5 %
Residual solvents (ICH Q3C)excluded by the production process
Proteins and UV-absorbing impuritiespasses test
Sulfated ash≤ 0.1 %
Sulfated ash (ChP)≤ 0.1 %
Loss on drying (80 °C, 2 h)≤ 0.5 %
Water4.5 - 5.5 %
Endotoxins< 50
Microbiological purity (Total aerobic microbial count (TAMC))≤ 100 CFU/g
Microbiological purity (Total yeast and mould count (TYMC))≤ 50 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
1370455000 04027269071981
1370459029 04027269061678

Documentation

Material Qualification Dossier

TitleVersion
6.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Laktóza monohydrát MSDS

Title

Safety Data Sheet (SDS) 

Laktóza monohydrát Certificates of Analysis

Product Number PackagingSpecificationLot Number
1370455000 Plastová flašaPDF Specification Document
1370459029 Dvojité PE vreckoPDF Specification Document

Certificates

Title