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111597 Parteck® SI 400 LEX (Sorbitol)

EMPROVE® EXPERT Ph Eur,BP,NF,JP

Parteck® SI 400 LEX (Sorbitol) MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: D-Glucitol

CAS #: 50-70-4 EC Number: 200-061-5 Molar Mass: 182.17 g/mol Hill Formula: C₆H₁₄O₆ Grade: Ph Eur,BP,NF,JP
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111597
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Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
50-70-4200-061-5C₆H₁₄O₆182.17 g/molPh Eur,BP,NF,JP

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      1115979028
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          Description
          Catalogue Number111597
          SynonymsD-Glucitol
          References
          Product Information
          CAS number50-70-4
          EC number200-061-5
          GradePh Eur,BP,NF,JP
          Hill FormulaC₆H₁₄O₆
          Molar Mass182.17 g/mol
          HS Code2905 44 00
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.49 g/cm3 (20 °C)
          Ignition temperature420 °C
          Melting Point94 - 96 °C
          pH value5.0 - 7 (182 g/l, H₂O, 25 °C)
          Vapor pressure<0.1 hPa (25 °C)
          Bulk density450 kg/m3
          Solubility2350 g/l
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Rat 15900 mg/kg
          Safety Information according to GHS
          RTECSLZ4290000
          Storage class10 - 13 Other liquids and solids
          WGKWGK 1 slightly 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 +2°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)97.0 - 100.5 %
          Identitypasses test
          pH-value (10 %; water)3.5 - 7.0
          Appearance of solution (25 %; water)passes test
          Spec. rotation (α20/D, 10 %, borate complex, calc. on anhydrous substance)+4.0 - +7.0 °
          Conductivity (25°C) (20 %; water)≤ 20
          Chloride (Cl)≤ 0.002 %
          Sulfate (SO₄)≤ 0.006 %
          Heavy metals (as Pb)≤ 5 ppm
          As (Arsenic)≤ 1.0 ppm
          Ni (Nickel) (#)≤ 1 ppm
          Related substances (HPLC, Ph. Eur.) (major impurity)≤ 2.0 %
          Related substances (HPLC, EP) (Sum of all impurities)≤ 3.0 %
          Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.8
          Reducing sugars (as glucose)≤ 0.11 %
          Sulfated ash≤ 0.02 %
          Loss on drying≤ 2.0 %
          Water≤ 1.5 %
          Residual solvents (ICH Q3C)excluded by manufacturing process
          Microbiological testpasses test
          Colony count (aerobic bacteria (TAMC))≤ 10²
          Colony count (Yeasts and moulds (TYMC))≤ 10²
          Salmonella spp.in 10g Substance not detectable
          E.coliin 1g substance not detectable
          Pseudomonas aeruginosain 1g substance not detectable
          Staphylococcus aureusin 1g substance not detectable
          Candida albicansIn 1g substance not detectable
          Endotoxins≤ 1
          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, NF, JP
          Global Trade Item Number
          Catalogue Number GTIN
          1115972500 04027269130848
          1115979028 04022536936468

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Required Licenses

          Title
          CARTA DE USO GENERAL 2016
          PRODUCTO REGULADO POR OTRAS SECRETARíAS

          Parteck® SI 400 LEX (Sorbitol) SDS

          Title

          Safety Data Sheet (SDS) 

          Parteck® SI 400 LEX (Sorbitol) Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1115972500 Plastic bottlePDF Specification Document
          1115979028 Fibre cartonPDF Specification Document

          Certificates

          Title

          Related Products & Applications

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          Categories

          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Parteck Excipients > Parteck SI (Sorbitol)
          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers