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102994 Sorbitol liquid

Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,ChP,USP,E 420

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1029949050
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      Steel barrel 50 kg
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      CO1E1029949050
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          CO1E1029949270
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              Description
              Catalogue Number102994
              SynonymsKarion
              References
              Product Information
              GradePh Eur,BP,ChP,USP,E 420
              HS Code2905 44 00
              Structure formula ImageStructure formula Image
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Density1.3 g/cm3
              pH value6 (H₂O, 20 °C) (50% solution)
              Dimensions
              Materials Information
              Toxicological Information
              Safety Information according to GHS
              Safety Information
              Product Usage Statements
              Storage and Shipping Information
              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
              Solid matter69.0 - 72.0 %
              Sorbitol (HPLC, calc.on anhydrous substance)92.0 - 101.0 %
              Sorbitol (HPLC)≥ 65.0 %
              Identitypasses test
              Identity (wet chemistry)passes test
              Appearance of solution (14 %; water)passes test
              pH-value (14 %; water)5.0 - 7.5
              conductivity (25°C)≤ 10
              Spec. rotation [α²0/D (14%, borate complex)(calc. on anhydrous substance)0.0 - 1.5 °
              As (Arsenic)≤ 1 ppm
              Ni (Nickel) (calc. on anhydrous substance) (*)≤ 1 ppm
              Pb (Lead) (calc. on anhydrous substance)≤ 0.5 ppm
              Diethylene glycol (GC)≤ 0.10 %
              Ethylene glycol (GC)≤ 0.10 %
              Reducing sugars after hydrolysis/total sugar (as glucose)≤ 0.5
              Reducing sugars (as glucose)≤ 0.2
              Residual solvents (ICH Q3C)excluded by manufacturing process
              Sulfated ash (calc.on anhydrous substance)≤ 0.1
              Water28.5 - 31.0 %
              Microbiological testpasses test
              Colony count (aerobic bacteria (TAMC))(ChP)≤ 10³
              Colony count (Yeasts and moulds (TYMC))(ChP)≤ 10²
              E.coli (ChP)in 1g substance not detectable
              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, USP, E 420
              Conforms to the purity criteria on food additives according to the current European Commission Regulation.
              Global Trade Item Number
              Catalogue Number GTIN
              1029949050 04022536038681
              CO1E1029949050 0
              CO1E1029949270 0

              Documentation

              Material Qualification Dossier

              TitleVersion
              9.1

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              Sorbitol liquid SDS

              Title

              Safety Data Sheet (SDS) 

              Sorbitol liquid Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1029949050 Steel barrelPDF Specification Document
              CO1E1029949050 PDF Specification Document
              CO1E1029949270 PDF Specification Document

              Certificates

              Title