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137045 Lactoza monohidrat

pulbere, adecvata pentru productia biofarmaceutica EMPROVE® EXPERT Ph Eur,BP,ChP,NF,JP

Lactoza monohidrat 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

Pricing & Availability

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1370455000
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      		 Plastic bottle 5 kg
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      1370459029
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          		 Double PE Sack 25 kg
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          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 Rat > 10000 mg/kg
          Safety Information according to GHS
          RTECSOD9625000
          Storage class10 - 13 Alte lichide sau solide
          WGKWGK 2 poluare a apei
          Disposal3
          Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageA se depozita între +15°C la +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

          Emprove Dossier

          TitleVersion
          6.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Lactoza monohidrat MSDS

          Title

          Safety Data Sheet (SDS) 

          Lactoza monohidrat Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1370455000 Plastic bottlePDF Specification Document
          1370459029 Double PE SackPDF Specification Document

          Certificates

          Title