102975 Sorbitol FP liquid

Overview

Replacement Information

Key Specifications Table

Grade Value
Ph Eur,BP,NF,E 420

Pricing & Availability

Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
1029759050
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      Steel barrel 50 kg
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      1029759270
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      Discontinued
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      Available
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          Steel barrel 270 kg
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          Description
          Catalogue Number102975
          SynonymsSorbit®, Sorbitol®, Sionon®, Sorbo®
          References
          Product Information
          GradePh Eur,BP,NF,E 420
          HS Code3824 60 19
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.3 g/cm3 (20 °C)
          pH value6 (H₂O, 20 °C) (50% solution)
          Dimensions
          Materials Information
          Toxicological Information
          Safety Information according to GHS
          Storage class10 - 13 Other liquids and solids
          WGKNWG not water endangering
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageStore at +5°C to +30°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
          Solid matter69.0 - 72.0 %
          Sorbitol (HPLC, calc.on anhydrous substance)72.0 - 92.0 %
          Sorbitol (HPLC)≥ 50.0 %
          Identitypasses test
          pH-value (14 %; water)5.0 - 7.5
          Appearance of solution (14 %; water)passes test
          conductivity (25°C)≤ 10
          As (Arsenic)≤ 1 ppm
          Ni (Nickel) (#)≤ 1 ppm
          Pb (Lead)≤ 0.5 ppm
          Ethylene glycol (HPLC)≤ 0.10 %
          Diethylene glycol (HPLC)≤ 0.10 %
          Mannitol (HPLC)≤ 6.5
          Reducing sugars after hydrolysis/total sugar (as glucose)≤ 9.3 %
          Reducing sugars (as glucose)≤ 0.2
          Sulfated ash≤ 0.1
          Water28.5 - 31.0 %
          Residual solvents (ICH Q3C)excluded by manufacturing process
          Microbiological testpasses test
          Colony count (aerobic bacteria (TAMC))≤ 1000 CFU/ml
          Colony count (Yeasts and moulds (TYMC))≤ 100 CFU/ml
          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, E 420
          Conforms to the purity criteria on food additives according to the current European Commission Regulation.

          Documentation

          Material Qualification Dossier

          Title

          Quality Management Dossier

          Title

          Operational Excellence Dossier

          Title

          Sorbitol FP liquid SDS

          Title

          Safety Data Sheet (SDS) 

          Sorbitol FP liquid Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1029759050 Steel barrelPDF Specification Document
          1029759270 Steel barrelPDF Specification Document

          Certificates

          Title
          Kosher Certificate for 102975 Sorbitol FP liquid (sorbitol syrup, noncrystallizing) suitable for use as excipient EMPROVE® exp Ph Eur,BP,E 420