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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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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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              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

              Documentation

              Material Qualification Dossier

              TitleVersion
              9.1

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Required Licenses

              Title
              CARTA DE USO GENERAL 2016
              PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

              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

              Certificates

              Title