Tests

Specification

Results

Description

White or almost white crystalline powder

Complies

Solubility  

Soluble in diluted hydrochloric acid;slightly soluble in water;insoluble in alcohol.

Complies

Identification

Infrared absorption should conform

Complies

HPLC retention time should conform

Complies

Organic volatile impurities

Maximum 0.1 percent

＜0.1%

Related substance

TLC

Maximum 0.5.percent

0.30%

HPLC

guanine: Maximum 0.7percent

0.32%

single impurity : Maximum 0.5percent

0. 35%

 impurities :Maximum 1.0.percent

0.46%

Sulphated Ash  

Not more than 0.1%  

0.02%

Water

Not more than 6.0%

5.1%

Assay (**)   

98.5-101%

99.4%

Tapped density

0.32-0.40g/ml

0.32 g/ml

Particle size

100% pass 20um by laser

 90% pass 10um by laser

Complies

Residual solvents

Toluene

Not more than 890PPM

＜0.018%

CONCLUSION: THE RESULTS CONFORM WITH USP 38 STANDARD.