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100242 Citric acid monohydrate

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
5949-29-1201-069-1C₆H₈O₇ * H₂O210.14 g/molPh Eur,BP,ChP,JP,USP,E 330,FCC

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      Double PE Sack 25 kg
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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,ChP,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 value1.8 (50 g/l, H₂O, 20 °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.
      H335: May cause respiratory irritation.
      Precautionary Statement(s)P261: Avoid breathing dust.
      P264: Wash skin thoroughly after handling.
      P271: Use only outdoors or in a well-ventilated area.
      P280: Wear eye protection/ face protection.
      P304 + P340 + P312: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/doctor if you feel unwell.
      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
      Categories of dangerirritant
      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
      Identity (wet chemistry)passes test
      Appearancewhite to almost white or colorless crystals
      Appearance of solution (200 g/l; water)clear (≤ 1.5 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
      Chloride (Cl)≤ 5 ppm
      Sulfate (SO₄)≤ 50 ppm
      Heavy metals (as Pb)≤ 5 ppm
      Al (Aluminium)≤ 0.2 ppm
      As (Arsenic)≤ 1 ppm
      Ca (Calcium)passes test
      Fe (Iron)≤ 10 ppm
      Hg (Mercury)≤ 1 ppm
      Pb (Lead)≤ 0.5 ppm
      Oxalates (as C₂H₂O₄)≤ 100 ppm
      Oxalate (C₂H₂O₄) (ChP)passes test
      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, ChP, JP, USP, E 330, FCC
      Conforms to the purity criteria on food additives according to the current European Commission Regulation.
      Global Trade Item Number
      Catalogue Number GTIN
      1002429029 04022536939742

      Documentation

      Material Qualification Dossier

      TitleVersion
      9.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Citric acid monohydrate SDS

      Title

      Safety Data Sheet (SDS) 

      Citric acid monohydrate Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1002429029 Double PE SackPDF Specification Document

      Certificates

      Title

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      Categories

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