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Mubychem Group, established in
1976, is the pioneer manufacturer of Zinc Chloride, Ammonium
Chloride, Calcium Chloride, Potassium Chloride, Sodium Acetate,
Sodium Thiosulphate, Pharmaceutical, Fragrance & Flavor chemicals in
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British Pharmacopoeia 2009
Urea British Pharmacopoeia
Urea BP
CH4N2Oıı60.1ıı
57-13-6
Action and use
Keratolytic.
DEFINITION
Carbamide.
Content
98.5 per cent to 101.5 per cent (dried substance).
CHARACTERS
Appearance
White or almost white, crystalline powder or transparent
crystals, slightly hygroscopic.
Solubility
Very soluble in water, soluble in alcohol, practically
insoluble in methylene chloride.
IDENTIFICATION
First identification
A, B.
Second identification A, C, D.
A. Melting point: 132 °C to 135 °C.
B. Infrared absorption spectrophotometry.
C. Dissolve 0.1 g in 1 ml of
water. Add 1 ml of nitric acid. A white, crystalline precipitate is formed.
D. Heat 0.5 g in a test tube until it liquefies and the
liquid becomes turbid. Cool, dissolve in a mixture of 1 ml of dilute sodium
hydroxide solution and 10 ml of water and add 0.05 ml of copper
sulphate solution. A reddish-violet colour is produced.
TESTS
Solution S
Dissolve 10.0 g in
water and dilute to 50 ml with
the same solvent.
Appearance of solution
The solution is clear and colourless.
To 2.5 ml of solution S add 7.5 ml of
water.
Alkalinity
To 2.5 ml of solution S add 7.5 ml of
water, 0.1 ml
of methyl red solution and 0.4 ml of 0.01 M hydrochloric acid .
The solution is red to orange.
Biuret
Maximum 0.1 per cent.
Ammonium
Maximum 500 ppm, determined on 0.1 ml of solution S.
Heavy metals
Maximum 10 ppm.
Loss on drying
Maximum 1.0 per cent, determined on 1.000 g by drying in an
oven at 105 °C for 1 h.
Sulphated ash
Maximum 0.1 per cent, determined on 1.0 g.
Urea USP
Urea
CH4N2O 60.06
Urea.
Carbamide.
Urea contains not less than 99.0 percent and not more than 100.5 percent of CH4N2O.
Labeling— Where it is intended for use in preparing
injectable dosage forms, the label states that it is sterile or must be
subjected to further processing during the preparation of injectable dosage
forms.
Identification—
A: Heat about 500 mg in a test tube: it liquefies,
and ammonia is evolved. Continue the heating until the liquid becomes turbid,
then cool. Dissolve the fused mass in a mixture of 10 mL of water and 1 mL of
sodium hydroxide solution (1 in 10), and add 1 drop of cupric sulfate TS: the
solution acquires a reddish-violet color.
B: Dissolve 100 mg in 1 mL of water, and add 1 mL of
nitric acid: a white crystalline precipitate of urea nitrate is formed.
Melting range: between 132 and 135 .
Residue on ignition: not more than 0.1%.
Alcohol-insoluble matter—0.04%.
Chloride— 0.007%.
Sulfate— 0.010%.
Heavy metals— the limit is 0.002%.
Other requirements— Where the label states that Urea
is sterile, it meets the requirements for Sterility Tests 71 and for Bacterial endotoxins
under Urea for Injection. Where the label states
that Urea must be subjected to further processing during the preparation of
injectable dosage forms, it meets the requirements for Bacterial endotoxins
under Urea for Injection.
Urea FCC
Carbamide
CH4N2O Formula wt 60.06
CAS: [57-13-6]
DESCRIPTION
Urea occurs as a colorless to white, prismatic, crystalline
powder or as small, white pellets. It is commonly produced from CO2 by
ammonolysis or from cyanamide by hydrolysis. It is freely soluble in water and
in boiling alcohol, but practically insoluble in chloroform and in ether. It
melts at a range of 132° to 135°.
Function Fermentation aid.
REQUIREMENTS
Identification
A. Heat about 500 mg of sample in a test tube until it
liquefies. Ammonia vapor is produced. Continue heating until the liquid becomes
turbid, and then cool. Dissolve the fused mass in a 1:10 sodium hydroxide
solution:water mixture. Add 1 drop of cupric sulfate TS. A red-violet colored
solution develops.
B. Dissolve 100 mg of sample in 1 mL of water, and add 1 mL
of nitric acid. A white precipitate of urea nitrate forms.
Assay Not less than 99.0% and not more than 100.5%
of CH4N2O.
Alcohol-Insoluble Matter Not more than 0.04%.
Chloride Not more than 0.007%.
Lead Not more than 5 mg/kg.
Loss on Drying
Not more than 1.0%.
Residue on Ignition
Not more than 0.1%.
Sulfate Not more than 0.01%.
Urea ACS
ACS Specifications
Urea
NH2CONH2
Formula Wt 60.06
CAS Number 57-13-6
REQUIREMENTS
|
Assay |
99.0-100.5% |
|
Melting point |
132-135 |
C
MAXIMUM ALLOWABLE
|
Insoluble matter |
0.01% |
|
Residue after ignition |
0.01% |
|
Chloride (Cl) |
5 ppm |
|
Sulfate (SO4) |
0.001% |
|
Heavy metals (as Pb) |
0.001% |
|
Iron (Fe) |
0.001% |
More from Urea 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
29 April, 2010
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