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107656 Lactose monohydrate

powder EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,NF

Lactose monohydrate 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,JP,NF
107656
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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,JP,NF

Pricing & Availability

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1076569029
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      		 Double PE Sack 25 kg
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      1076569525
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          		 Double PE Sack 21 x 25 kg
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          Description
          Catalogue Number107656
          SynonymsMilk sugar, Lactobiose
          References
          Product Information
          CAS number10039-26-6
          EC number200-559-2
          GradePh Eur,BP,ChP,JP,NF
          Hill FormulaC₁₂H₂₂O₁₁ * H₂O
          Molar Mass360.32 g/mol
          HS Code1702 11 00
          Structure formula ImageStructure formula Image
          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 Other liquids and solids
          WGKWGK 2 obviously hazardous to water
          Disposal3
          Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageStore at +15°C to +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 manufacturing process
          Proteins and UV-absorbing impuritiespasses test
          Sulfated ash≤ 0.1 %
          Loss on drying (80 °C, 2 h)≤ 0.5 %
          Water4.5 - 5.5 %
          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
          Corresponds to Ph Eur, BP, ChP, JP, NF
          Global Trade Item Number
          Catalogue Number GTIN
          1076569029 04022536947839
          1076569525 04022536947846

          Documentation

          Material Qualification Dossier

          TitleVersion
          10.1

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Required Licenses

          Title
          PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

          Lactose monohydrate SDS

          Title

          Safety Data Sheet (SDS) 

          Lactose monohydrate Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1076569029 Double PE SackPDF Specification Document
          1076569525 Double PE SackPDF Specification Document

          Certificates

          Title