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137003 Kyselina citrónová monohydrát

kryštalická, vhodná pre biofarmaceutickú výrobu EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

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
137003
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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

Products

Catalogue NumberPackaging Qty/Pack
1370030001 Kartónová krabica 3 x 1 kg
1370031000 Plastová flaša 1 kg
1370035000 Plastová flaša 5 kg
1370039012 Plastové vedro 12 kg
1370039029 Dvojité PE vrecko 25 kg
Description
Catalogue Number137003
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
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 +15°C až +25°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
Oxalates (as C₂H₂O₄)≤ 360 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 - 9.0 %
Total aerobic microbial count (TAMC)≤ 100 CFU/g
Total combined yeasts/moulds count (TYMC)≤ 10 CFU/g
Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
Candida albicans (absent in 1 g)passes test
Escherichia coli (absent in 1 g)passes test
Pseudomonas aeruginosa (absent in 1 g)passes test
Salmonella (absent in 10 g)passes test
Staphylococcus aureus (absent in 1 g)passes test
DNases (Exo- and endonucleases)not detectable
RNasesnot detectable
Bacterial endotoxins< 10

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
Global Trade Item Number
Catalogue Number GTIN
1370030001 04027269365233
1370031000 04027269364946
1370035000 04027269061432
1370039012 04027269077426
1370039029 04027269061968

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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Kyselina citrónová monohydrát MSDS

Title

Safety Data Sheet (SDS) 

Kyselina citrónová monohydrát Certificates of Analysis

Product Number PackagingSpecificationLot Number
1370030001 Kartónová krabicaPDF Specification Document
1370031000 Plastová flašaPDF Specification Document
1370035000 Plastová flašaPDF Specification Document
1370039012 Plastové vedroPDF Specification Document
1370039029 Dvojité PE vreckoPDF Specification Document

Certificates

Title