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137045 Laktoza, monohydrat

proszek EMPROVE® EXPERT Ph Eur,BP,ChP,NF,JP

Laktoza, monohydrat 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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Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1370455000 Butelka plastikowa 5 kg
1370459029 Podwójny worek PE 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 Szczur > 10000 mg/kg
Safety Information according to GHS
RTECSOD9625000
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKWGK 2 zanieczyszczenie wody
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +15°C do +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
Numer katalogowy GTIN
1370455000 04027269071981
1370459029 04027269061678

Documentation

Emprove Dossier

TitleVersion
6.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Laktoza, monohydrat MSDS

Title

Safety Data Sheet (SDS) 

Laktoza, monohydrat Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1370455000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1370459029 Podwójny worek PEDokument ze specyfikacją, w formacie PDF

Certificates

Title