|
Appearance
|
White hygroscopic crystalline powder
|
|
Assay (By HPLC; on anhydrous basis)
|
94.0 - 102.0 %
|
|
Identity
|
Passes test
|
|
Appearance of solution
|
Passes test
|
|
pH (0.1% solution in water)
|
9.5-10.5
|
|
Chloride (Cl)
|
Max 0.033%
|
|
Sulphate (SO4)
|
Max 0.03%
|
|
Heavy metal (as Pb)
|
Max 0.001%
|
|
Water (H2O)
|
Max 5.0%
|
|
Related Substances
|
-
|
|
Impurity A
|
Max 4.0%
|
|
Unspecified impurities
|
Max 0.5%
|
|
Sum of impurities other than A
|
Max 1.0%
|