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100242 Citric acid monohydrate

Overview

Replacement Information

Key Specifications Table

CAS #EC NumberHill FormulaMolar MassGrade Value
5949-29-1 201-069-1 C₆H₈O₇ * H₂O 210.14 g/mol Ph Eur,BP,JP,USP,E 330,FCC

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      1.00242.9029
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          Description
          Catalogue Number100242
          Synonyms2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid
          References
          Product Information
          CAS number5949-29-1
          EC number201-069-1
          GradePh Eur,BP,JP,USP,E 330,FCC
          Hill FormulaC₆H₈O₇ * H₂O
          Molar Mass210.14 g/mol
          HS Code2918 14 00
          Structure formula ImageStructure formula Image
          Quality LevelMQ500
          Applications
          Biological Information
          Physicochemical Information
          Density1.54 g/cm3 (20 °C)
          Flash point173.9 °C Not applicable
          Melting Point135 - 152 °C
          pH value1.85 (50 g/l, H₂O, 25 °C)
          Vapor pressure<1 Pa (25 °C)
          Bulk density800 - 1000 kg/m3
          Solubility880 g/l
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Rat 3000 mg/kg
          Safety Information according to GHS
          Hazard Pictogram(s) Hazard Pictogram(s)
          Hazard Statement(s)H319: Causes serious eye irritation.
          Precautionary Statement(s)P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
          Signal WordWarning
          RTECSGE7810000
          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
          Hazard Symbols Hazard SymbolsIrritant
          Categories of dangerirritant
          R PhraseR 36
          Irritating to eyes.
          S PhraseS 26
          In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
          Product Usage Statements
          Storage and Shipping Information
          StorageStore at +2°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
          Assay (alkalimetric, calculated on anhydrous substance)99.5 - 100.5 %
          Identity (IR-spectrum)passes test
          Appearancewhite to almost white or colorless crystals
          Appearance of solution (200 g/l; water)clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
          Sulfate (SO₄)≤ 50 ppm
          Heavy metals (as Pb)≤ 5 ppm
          Al (Aluminium)≤ 0.2 ppm
          As (Arsenic)≤ 1 ppm
          Hg (Mercury)≤ 1 ppm
          Pb (Lead)≤ 0.5 ppm
          Oxalates (as C₂H₂O₄)≤ 100 ppm
          Residual solvents (ICH (Q3C))excluded by manufacturing process
          Readily carbonisable substancepasses test
          Sulfated ash (600 °C)≤ 0.05 %
          Water (according to Karl Fischer)7.5 - 8.8 %
          Bacterial endotoxins< 0.5
          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, JP, USP, E 330, FCC
          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

          Citric acid monohydrate SDS

          Title

          Safety Data Sheet (SDS) 

          Citric acid monohydrate Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1002425000 Plastic bottlePDF Specification Document
          1.00242.9029 Double PE SackPDF Specification Document

          Certificates

          Title

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          Categories

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          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > pH Adjustment
          Small Molecule Pharmaceuticals > Formulation > Solid Dosage Form > Taste Modifiers
          Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Taste Modifiers
          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Taste Modifiers
          Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers