Pharmaceutical excipients
Urea

Product name

Urea

Specification

Pharmaceutical grade (USP,BP,EP,CP)

Molecular formula

CO(NH2)2

CAS

57-13-6

H.S. CODE

3102100090

Molecular weight

60.05

Appearance

White crystal powder

Package

25KG Woven bags or fiber drums


Property

     White shape crystallization or white powder. Melting point 132.7 ℃ (breakdown). Soluble in water, alcohol and benzene, slightly soluble in ether, insoluble in trichloromethane

Application:

    Analytics reagents, stabilizer. Also used in organic synthesis.

Test standard

Test items

Specification

BP2015

USP35

CP2015

Appearance

White crystal powder

White crystal powder

White crystal powder

Assay

98.5~101.5%

98.5~101.5%

99.5%

Appearance of solution

Conform

 

 

Melting point

 

132~135℃

132~135℃

Alkaline

Conform

 

 

Residue on ignition

 

0.1%

0.1%

Ethanol insoluble matter

 

0.04%

Conform

Chloride

 

0.007%

0.007%

Sulfate

 

0.010%

0.01%

Biuret

0.1%

 

 

Ammonium

0.05%

 

 

Heavy metal

0.001%

0.002%

0.002%

Loss on dry

1.0%

 

 

Sulfated ash

0.1%

 

 

Bacterial endotoxin

 

Conform

 

Storage

    Store in a cool, dry and well ventilated place. Keep away from incompatible substances. Keep container closed.


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