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111597 Parteck® SI 400 LEX (Sorbitol)

Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

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1115971003
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      Plastic bottle 1 kg
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      1115972500
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          Plastic bottle 2.5 kg
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          1115979012
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              Plastic drum 12 kg
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              1115979024
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                  Plastic drum 25 kg
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                  1115979028
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                      Fibre carton 25 kg
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                      1115979050
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                          50 kg
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                          1115979503
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                              Big Bag 500 kg
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                              CO1E1115979028
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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
                                  1115971003 04027269171643
                                  1115972500 04027269130848
                                  1115979012 04027269138134
                                  1115979024 04027269170844
                                  1115979028 04022536936468
                                  1115979050 04022536133720
                                  1115979503 04027269021276
                                  CO1E1115979028 04061839802223

                                  Documentation

                                  Material Qualification Dossier

                                  TitleVersion
                                  9.0

                                  Quality Management Dossier (Open Access)

                                  Title

                                  Operational Excellence Dossier

                                  Title

                                  Parteck® SI 400 LEX (Sorbitol) SDS

                                  Title

                                  Safety Data Sheet (SDS) 

                                  Parteck® SI 400 LEX (Sorbitol) Certificates of Analysis

                                  Product Number PackagingSpecificationLot Number
                                  1115971003 Plastic bottlePDF Specification Document
                                  1115972500 Plastic bottlePDF Specification Document
                                  1115979012 Plastic drumPDF Specification Document
                                  1115979024 Plastic drumPDF Specification Document
                                  1115979028 Fibre cartonPDF Specification Document
                                  1115979050 PDF Specification Document
                                  1115979503 Big BagPDF Specification Document
                                  CO1E1115979028 PDF 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