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108195 Lactose monohydrate

(milk sugar) special grade for tabletting 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
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108195
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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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1081959029
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      		 Double PE Sack 25 kg
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      1081959525
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          		 Double PE Sack 21 x 25 kg
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          CO1E1081959029
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              		 25 kg
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              CO1E1081959525
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                  		 525 kg
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                  Description
                  Catalogue Number108195
                  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 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 %
                  Particle size (< 100 µm)≤ 50 %
                  Particle size (> 250 µm)≤ 2 %
                  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
                  1081959029 04022536947884
                  1081959525 04022536947891
                  CO1E1081959029 04061839010222
                  CO1E1081959525 04061839010239

                  Documentation

                  Material Qualification Dossier

                  TitleVersion
                  9.0

                  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
                  1081959029 Double PE SackPDF Specification Document
                  1081959525 Double PE SackPDF Specification Document
                  CO1E1081959029 PDF Specification Document
                  CO1E1081959525 PDF Specification Document

                  Certificates

                  Title