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102975 Cairan Sorbitol FP

(sirup sorbitol, tidak mengkristal) sesuai untuk digunakan sebagai eksipien EMPROVE® ESSENTIAL Ph Eur,BP,NF,E 420

Cairan Sorbitol FP MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Sorbit®, Sorbitol®, Sionon®, Sorbo®

Grade: Ph Eur,BP,NF,E 420
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102975
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Overview

Replacement Information

Key Spec Table

Grade Value
Ph Eur,BP,NF,E 420

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1029752500
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      		 Botol kaca 2.5 l
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      1029759270
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          		 Barel baja 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 00
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.3 g/cm3 (20 °C)
          pH value6 (H₂O, 20 °C) (larutan 50%)
          Dimensions
          Materials Information
          Toxicological Information
          Safety Information according to GHS
          Storage class10 - 13 Cairan dan padatan lain
          WGKWGK 1 agak berbahaya untuk air
          Safety Information
          Product Usage Statements
          Storage and Shipping Information
          StorageSimpan pada +15°C hingga +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
          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) (calc. on anhydrous substance) (*)≤ 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 (calc.on anhydrous substance)≤ 0.1
          Water28.5 - 31.0 %
          Residual solvents (ICH Q3C)excluded by manufacturing process
          Microbiological testpasses test
          Colony count (aerobic bacteria (TAMC))≤ 10³
          Colony count (Yeasts and moulds (TYMC))≤ 10²
          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.
          Global Trade Item Number
          Catalogue Number GTIN
          1029752500 04065267183756
          1029759270 04022536038476

          Documentation

          Material Qualification Dossier

          TitleVersion
          11.1

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Cairan Sorbitol FP MSDS

          Title

          Safety Data Sheet (SDS) 

          Cairan Sorbitol FP Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1029752500 Botol kacaPDF Specification Document
          1029759270 Barel bajaPDF Specification Document

          Certificates

          Title