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100243 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

Pricing & Availability

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1002431000
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      1002439025
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          1002439026
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              1.00243.9029
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                  Double PE Sack 25 kg
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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,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, fine powder
                  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 %
                  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, JP, USP, E 330, FCC
                  Conforms to the purity criteria on food additives according to the current European Commission Regulation.

                  Documentation

                  Material Qualification Dossier

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                  Quality Management Dossier

                  Title

                  Operational Excellence Dossier

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                  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
                  1.00243.9029 Double PE SackPDF Specification Document

                  Certificates

                  Title

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                  Categories

                  Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers
                  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