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100243 Citric acid monohydrate

powder 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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100243
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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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      1.00243.9025
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          1.00243.9029
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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
              1.00243.1000 04022536003351
              1.00243.9025 04022536003375
              1.00243.9029 04022536939759

              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
              1.00243.1000 Plastic bottlePDF Specification Document
              1.00243.9025 Fibre cartonPDF Specification Document
              1.00243.9029 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