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Citric Acid Monohydrate
Citric Acid Monohydrate BP
C6H8O7,H2Oıı210.1ıı5949-29-1
DEFINITION
2-Hydroxypropane-1,2,3-tricarboxylic acid monohydrate.
Content
99.5 per cent to 100.5 per cent
(anhydrous substance).
CHARACTERS
Appearance
White or almost white, crystalline
powder, colourless crystals or granules, efflorescent.
Solubility
Very soluble in water, freely
soluble in ethanol (96 per cent).
IDENTIFICATION
First identification B,
E.
Second identification A,
C, D, E.
A. Dissolve 1 g in 10 ml of water. The solution is strongly acidic.
B. Infrared absorption
spectrophotometry.
C. Add about 5 mg to a mixture of
1 ml of acetic anhydride and 3 ml of pyridine. A red colour
develops.
D. Dissolve 0.5 g in 5 ml of water, neutralize using 1 M sodium hydroxide
(about 7 ml), add 10 ml
of calcium chloride solution R and heat to boiling. A white precipitate
is formed.
E. Water (see Tests).
TESTS
Appearance of solution
The solution is clear and
not more intensely coloured than reference.
Dissolve 2.0 g in water and
dilute to 10 ml with the same solvent.
Readily carbonizable substances
To 1.0 g in a cleaned test tube
add 10 ml of sulphuric acid and immediately heat the mixture in a
water-bath at 90 ± 1 °C for 60 min. Cool rapidly immediately afterwards. The
solution is not more intensely coloured than a mixture of 1 ml of red primary
solution and 9 ml of yellow primary solution.
Oxalic acid
Maximum 360 ppm, calculated as
anhydrous oxalic acid.
Sulphates
Maximum 150 ppm.
Aluminium
Maximum 0.2 ppm, if intended for
use in the manufacture of dialysis solutions.
Heavy metals
Maximum 10 ppm.
Water
7.5 per cent to 9.0 per cent,
determined on 0.500 g.
Sulphated ash
Maximum 0.1 per cent, determined
on 1.0 g.
Bacterial endotoxins
Less than 0.5 IU/mg, if intended
for use in the manufacture of parenteral dosage forms without a further
appropriate procedure for the removal of bacterial endotoxins.
Citric
Acid Monohydrate USP
Citric Acid Monohydrate
C6H8O7·H2O 210.14
1,2,3-Propanetricarboxylic acid,
2-hydroxy-, monohydrate.
Citric Acid Monohydrate contains one molecule of water of hydration. It contains not less than 99.5 percent and not more than 100.5 percent of C6H8O7, calculated on the anhydrous basis.
Labeling— Where it is intended for use in dialysis solutions, it is so labeled. Where Citric Acid Monohydrate must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled. Where Citric Acid Monohydrate is sterile, it is so labeled.
USP Reference standards
—
Clarity of solution— To
meet the standard
Color of solution—
To meet
the standard
Identification, Infrared
Absorption 197K — Dry the substance to be examined at 105 for 2
hours.
Bacterial endotoxins — The level of bacterial endotoxins is such that the requirement in the
relevant dosage form monograph (s) in which Citric Acid Monohydrate is used can
be met.
Sterility —
Where
the label states that Citric Acid Monohydrate is sterile, it meets the
requirements for Sterility, in the relevant dosage form monograph (s) in
which Citric Acid Monohydrate is used.
Water: between 7.5% and
9.0%.
Residue on ignition:
not
more than 0.1%, determined on 1.0 g.
Readily carbonizable
substances— To pass the test
Sulfate— 0.015%.
Heavy metals:
0.001%.
Limit of oxalic acid—
0.036%.
Citric Acid FCC
C6H8O7 Formula wt, anhydrous
192.13
C6H8O7·H2O Formula wt, monohydrate
210.14
INS: 330 CAS: anhydrous [77-92-9]
CAS: monohydrate [5949-29-1]
DESCRIPTION
Citric Acid occurs as colorless,
translucent crystals or as a white, granular to fine, crystalline powder. It is
anhydrous or contains one molecule of water of hydration. The hydrous form is
efflorescent in dry air. It is odorless and has a strongly acid taste. One gram
is soluble in about 0.5 mL of water, in about 2 mL of alcohol, and in about 30
mL of ether.
Function Sequestrant;
dispersing agent; acidifier; flavoring agent.
REQUIREMENTS
Labeling
Indicate whether
it is anhydrous or hydrous.
Identification
A 1:10
aqueous solution gives positive tests for Citrate.
Assay
Not less than 99.5%
and not more than 100.5% of C6H8O7, calculated on the anhydrous basis.
Lead Not more than 0.5
mg/kg.
Oxalate Passes test.
Readily Carbonizable Substances
Passes test.
Residue on Ignition
Not
more than 0.05%.
Tridodecylamine
(for
solvent-extracted Citric Acid only)
Not more than 0.1 mg/kg.
Water Anhydrous: Not
more than 0.5%; Monohydrate: Not more than 8.8%.
Citric Acid ACS
Citric Acid, Anhydrous, and
Citric Acid, Monohydrate
2-Hydroxy-1,2,3-propanetricarboxylic Acid
HOCOCH2C(OH)(COOH)CH2COOH; Formula
Wt. 192.13
HOCOCH2C(OH)(COOH)CH2COOH
.
H2O;
Formula Wt. 210.14
CAS Number
77-92-9 (Anhydrous); 5949-29-1 (Monohydrate)
REQUIREMENTS
Assay 
99.5%
C6H8O7 99.0-102.0%
C6H8O7 .
H2O
MAXIMUM ALLOWABLE
Insoluble matter 0.005%
Residue after ignition 0.02%
Chloride (Cl) 0.001%
Oxalate (C2O4) Passes test
Phosphate (PO4) 0.001%
Sulfate (SO4) 0.002%
Iron (Fe) 3 ppm
Lead (Pb) 2 ppm
Substances carbonizable
by hot sulfuric acid Passes test
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More from Citric Acid Manufacturer at:
MUBY CHEMICALS
S-8, SARIFA MANSION, 2ND FLANK ROAD,
CHINCHBUNDER, MUMBAI 400009, INDIA.
TEL: (OFFICE) 91-22-23770100, 23726950,
23774610, 23723564. FAX: 91-22-23728264.
e-mail:
info@mubychem.com
Cell Call to Anmol: +91-9821870100 or Ambrish: +91-9821570100
Copyright and Usual Disclaimer is
Applicable.
Last updated
06 May, 2010
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