TESTS |
SPECIFICATION |
|
Description |
White or almost white crystalline powder |
|
Identification |
Infrared absorption should conform |
|
HPLC retention time should conform |
||
Color and clarity of solution |
Clear, not more intense than Y7 |
|
Sulphated Ash |
Not more than 0.1% |
|
Organic volatile impurities |
Maximum0.1percent |
|
Heavy metals |
≤10ppm |
|
Related substance |
TLC |
Maximum 0.5.percent |
HPLC |
guanine: Maximum 0.7percent |
|
single impurity : Maximum 0.5percent |
||
Total impurities :Maximum 1.0.percent |
||
Water |
Maximum6.0percent |
|
Assay (Anhydrous basis) |
98.5-101.0% |