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100242 Acid citric monohidrat

crist., adecvat pentru utilizare ca excipient EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,USP,E 330,FCC

Acid citric monohidrat 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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      		 Plastic bottle 5 kg
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      1002429029
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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 Nu se aplică
          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: Provoacă o iritare gravă a ochilor.
          H335: Poate provoca iritarea căilor respiratorii.
          Precautionary Statement(s)P261: Evitaţi să inspiraţi praful.
          P264: Spălaţi-vă pielea bine după utilizare.
          P271: A se utiliza numai în aer liber sau în spaţii bine ventilate.
          P280: Purtaţi echipament de protecţie a ochilor/ echipament de protecţie a feţei.
          P304 + P340 + P312: ÎN CAZ DE INHALARE: transportați persoana la aer liber și mențineți-o într-o poziție confortabilă pentru respirație. Sunați la un CENTRU DE INFORMARE TOXICOLOGICĂ/un medic dacă nu vă simțiți bine.
          P305 + P351 + P338: ÎN CAZ DE CONTACT CU OCHII: Clătiți cu atenție cu apă timp de mai multe minute. Scoateți lentilele de contact, dacă este cazul și dacă acest lucru se poate face cu ușurință. Continuați să clătiți.
          Signal WordAtenţie
          RTECSGE7810000
          Storage class10 - 13 Alte lichide sau solide
          WGKWGK 1 slabă contaminare a apei
          Disposal3
          Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
          Safety Information
          Categories of dangeriritant
          Product Usage Statements
          Storage and Shipping Information
          StorageA se depozita între +2°C la +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
          1002425000 04022536003306
          1002429029 04022536939742

          Documentation

          Emprove Dossier

          TitleVersion
          9.0

          Quality Management Dossier (Open Access)

          Title

          Operational Excellence Dossier

          Title

          Acid citric monohidrat MSDS

          Title

          Safety Data Sheet (SDS) 

          Acid citric monohidrat Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1002425000 Plastic bottlePDF Specification Document
          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