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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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개요

Replacement Information

주요 사양표

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

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              		 Fibre carton 25 kg
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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
              카탈로그 번호 GTIN
              1.11597.2500 04027269130848
              1.11597.9012 04027269138134
              1.11597.9028 04022536936468

              Documentation

              Material Qualification Dossier

              TitleVersion
              9.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Parteck® SI 400 LEX (Sorbitol) MSDS

              타이틀

              물질안전보건자료(MSDS) 

              Parteck® SI 400 LEX (Sorbitol) Certificates of Analysis

              제품 번호 패킹스펙로트(lot) 번호
              1.11597.2500 Plastic bottlePDF 사양 문건
              1.11597.9012 Plastic drumPDF 사양 문건
              1.11597.9028 Fibre cartonPDF 사양 문건

              Certificates

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              관련 제품 및 어플리케이션

              관련 제품: Brand Facete

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              카테고리

              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