Merck 100242 Citric Acid Monohydrate Cryst., Suitable For Use As Excipient Emprove® Exp pH Eur,Bp,Jp,Usp,E 330,Fcc. 25 kg

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MERCK

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LB.M.100242.9029

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Synonyms: 2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid CAS Number: 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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MERCK 100242 Citric acid monohydrate

cryst., suitable for use as excipient EMPROVE® exp Ph Eur, BP, JP, USP, E 330, FCC.

CAS 5949-29-1, pH (50 g/l, H₂O, 25 °C). 25 Kg

Description
Catalogue Number	100242
Synonyms	2-Hydroxypropane-1,2,3-tricarboxylic acid, Hydroxytricarballylic acid

Product Information
CAS number	5949-29-1
EC number	201-069-1
Grade	Ph Eur,BP,JP,USP,E 330,FCC
Hill Formula	C₆H₈O₇ * H₂O
Molar Mass	210.14 g/mol
HS Code	2918 14 00
Structure formula Image

Applications
Application	Citric acid monohydrate cryst., suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP,USP,E 330,FCC. CAS 5949-29-1, pH (50 g/l, H₂O, 25 °C).

Physicochemical Information
Density	1.54 g/cm3 (20 °C)
Flash point	173.9 °C Not applicable
Melting Point	135 - 152 °C
pH value	1.85 (50 g/l, H₂O, 25 °C)
Vapor pressure	<1 Pa (25 °C)
Bulk density	800 - 1000 kg/m3
Solubility	880 g/l

Toxicological Information
LD 50 oral	LD50 Rat 3000 mg/kg

Safety Information according to GHS
Hazard Pictogram(s)
Hazard Statement(s)	H319: Causes serious eye irritation.
Precautionary Statement(s)	P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
RTECS	GE7810000
Storage class	10 - 13 Other liquids and solids
WGK	WGK 1 slightly water endangering
Disposal	3 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
Hazard Symbols	Irritant
Categories of danger	irritant
R Phrase	R 36 Irritating to eyes.
S Phrase	S 26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Storage and Shipping Information
Storage	Store at +5 °C to +30 °C.

Transport Information
Declaration (railroad and road) ADR, RID	Kein Gefahrgut
Declaration (transport by air) IATA-DGR	No Dangerous Good
Declaration (transport by sea) IMDG-Code	No Dangerous Good

Specifications
Assay (alkalimetric, calculated on anhydrous substance)	99.5 - 100.5 %
Identity (IR-spectrum)	passes test
Appearance	white to almost white or colorless crystals
Appearance of solution (200 g/l; water)	clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇
Sulphate (SO₄)	≤ 50 ppm
Heavy metals (as Pb)	≤ 5 ppm
Al (Aluminium)	≤ 0.2 ppm
As (Arsenic)	≤ 1 ppm
Hg (Mercury)	≤ 1 ppm
Pb (Lead)	≤ 0.5 ppm
Oxalates (as C₂H₂O₄)	≤ 100 ppm
Residual solvents (ICH (Q3C))	excluded by manufacturing process
Readily carbonisable substance	passes 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, JP, USP, E 330, FCC Conforms to the purity criteria on food additives according to the current European Commission Regulation.

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