|
Appearance
|
White crystalline powder
|
|
Assay (by HPLC)
|
99.0 - 101.5%
|
|
Identity (IR)
|
Confirms to structure
|
|
Solubility
|
To comply BP, USP test
|
|
Identification
|
To comply IP, BP USP tests
|
|
Appearance of solution
|
To comply IP, BP test
|
|
Freezing point
|
69 - 70°C
|
|
Related Substances
|
To comply IP, BP test
|
|
Sulphated ash
|
Max 0.1%
|
|
Residue on ignition
|
Max 0.002%
|
|
Organic impurities
|
-
|
|
Individual impurity
|
Max 0.1%
|
|
Total impurities
|
Max 0.7%
|