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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

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1076565000
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      		 Plastic drum 5 kg
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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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              CO1E1076569029
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                  		 25 kg
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                  CO1E1076569525
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                      		 525 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 %
                      Sulfated ash (ChP)≤ 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
                      Global Trade Item Number
                      Catalogue Number GTIN
                      1076565000 04022536093505
                      1076569029 04022536947839
                      1076569525 04022536947846
                      CO1E1076569029 04061839010208
                      CO1E1076569525 04061839010215

                      Documentation

                      Material Qualification Dossier

                      TitleVersion
                      9.1

                      Quality Management Dossier (Open Access)

                      Title

                      Operational Excellence Dossier

                      Title

                      Lactose monohydrate SDS

                      Title

                      Safety Data Sheet (SDS) 

                      Lactose monohydrate Certificates of Analysis

                      Product Number PackagingSpecificationLot Number
                      1076565000 Plastic drumPDF Specification Document
                      1076569029 Double PE SackPDF Specification Document
                      1076569525 Double PE SackPDF Specification Document
                      CO1E1076569029 PDF Specification Document
                      CO1E1076569525 PDF Specification Document

                      Certificates

                      Title