|
Items |
Specification |
Results |
|
Appearnce |
White or almost white powder ,
Hygroscopic |
White powder ,hygroscopic |
|
Identification |
(1) HPLC: Positive |
Positive |
|
|
(2) Reaction (b) of potassium : positive |
Positve |
|
|
(3) reaction of silicates : positive |
Positive |
|
PH |
4.8-8.0 |
5.1 |
|
Polymeric impurities and other impurities absorbing at 578 nm |
NMT 0.40 |
0.025 |
|
Water |
NMT 2.5% |
0.51% |
|
Related substances |
Impurity E: NMT 1.0%
Any other single impurity (major)：NMT 0.10%
Total impurities : NMT 2.0% |
0.019%
＜0.05%
0.020% |
|
Assay (HPLC) |
91.2%-107.2% |
99.6% |
|
|
Clav.ACID 38.3%-45.0% |
41.8% |
|
|
CLAV.POT 45.6%-53.5% |
49.8% |
