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100243 Acid citric monohidrat

pulbere, 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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100243
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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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      		 Plastic bottle 1 kg
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      1002439025
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          		 Fibre carton 25 kg
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          1002439026
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              		 Plastic drum 25 kg
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              1002439029
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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,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 value1.85 (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: 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, 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

                  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
                  1002431000 Plastic bottlePDF Specification Document
                  1002439025 Fibre cartonPDF Specification Document
                  1002439026 Plastic drumPDF Specification Document
                  1002439029 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