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100243 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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1002431000
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      1002439025
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          1002439026
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              1002439029
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                                          Description
                                          Catalogue Number100243
                                          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 value1.85 (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.
                                          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, fine powder
                                          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 %
                                          Particle size (> 0.3 mm)≤ 5.0 %
                                          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
                                          1002431000 04022536003351
                                          1002439025 04022536003375
                                          1002439026 04027269164522
                                          1002439029 04022536939759
                                          CO1E1002431000 04061839008755
                                          CO1E1002439025 04061839008762
                                          CO1E1002439026 0
                                          CO1E1002439029 04061839008779
                                          CO1H1002439026 0
                                          CO1I1002439026 0

                                          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
                                          1002431000 Plastic bottlePDF Specification Document
                                          1002439025 Fibre cartonPDF Specification Document
                                          1002439026 Plastic drumPDF Specification Document
                                          1002439029 Double PE SackPDF Specification Document
                                          CO1E1002431000 PDF Specification Document
                                          CO1E1002439025 PDF Specification Document
                                          CO1E1002439026 PDF Specification Document
                                          CO1E1002439029 PDF Specification Document
                                          CO1H1002439026 PDF Specification Document
                                          CO1I1002439026 PDF Specification Document

                                          Certificates

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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