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100242 Citric acid monohydrate

cryst. EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,USP,E 330,FCC

Citric acid monohydrate MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid

CAS #: 5949-29-1 EC Number: 201-069-1 Molar Mass: 210.14 g/mol Hill Formula: C₆H₈O₇ * H₂O Grade: Ph Eur,BP,ChP,JP,USP,E 330,FCC
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100242
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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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      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,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
          1.00242.5000 04022536003306
          1.00242.9029 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
          1.00242.5000 Plastic bottlePDF Specification Document
          1.00242.9029 Double PE SackPDF Specification Document

          Certificates

          Title

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          Categories

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          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