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100242 Kyselina citrónová monohydrát

kryštalická, vhodná na použitie ako excipient EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,USP,E 330,FCC

Kyselina citrónová monohydrát 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
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

Products

Catalogue NumberPackaging Qty/Pack
1002425000 Plastová flaša 5 kg
1002429029 Dvojité PE vrecko 25 kg
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 Nepoužiteľné
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 Potkan 3000 mg/kg
Safety Information according to GHS
Hazard Pictogram(s) Hazard Pictogram(s)
Hazard Statement(s)H319: Spôsobuje vážne podráždenie očí.
H335: Môže spôsobiť podráždenie dýchacích ciest.
Precautionary Statement(s)P261: Zabráňte vdychovaniu prachu.
P264: Po manipulácii starostlivo umyte pokožku.
P271: Používajte iba na voľnom priestranstve alebo v dobre vetranom priestore.
P280: Noste ochranné okuliare/ ochranu tváre.
P304 + P340 + P312: PO VDÝCHNUTÍ: Presuňte osobu na čerstvý vzduch a umožnite jej pohodlne dýchať. Pri zdravotných problémoch volajte NÁRODNÉ TOXIKOLOGICKÉ INFORMAČNÉ CENTRUM/lekára.
P305 + P351 + P338: PO ZASIAHNUTÍ OČÍ: Niekoľko minút ich opatrne vyplachujte vodou. Ak používate kontaktné šošovky a je to možné, odstráňte ich. Pokračujte vo vyplachovaní.
Signal WordPozor
RTECSGE7810000
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Categories of dangerdráždivá
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +2°C až +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

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Kyselina citrónová monohydrát MSDS

Title

Safety Data Sheet (SDS) 

Kyselina citrónová monohydrát Certificates of Analysis

Product Number PackagingSpecificationLot Number
1002425000 Plastová flašaPDF Specification Document
1002429029 Dvojité PE vreckoPDF 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