當前頁面： 首頁 > 新聞中心新聞中心
CERTIFICATE OF ANALYSIS
PRODUCT NAME：KETOTIFEN FUMARATE
|
Batch No.: |
20201102 |
Date of Manufature |
2020.11.02 |
|
Batch Size |
30kg |
Certificate Date |
2020.11.02 |
|
Specification |
EP Ⅳ |
Date of Expiry |
2022.11 |
|
Test |
Specification |
Results |
|
|
Appearance |
White to brownish-yellow,fine,crystalline powder |
Complies |
|
|
Solubility |
Sparingly soluble in water , slightly soluble in Methanol , very slightly soluble in acetonifrile |
Complies |
|
|
Identification |
TLC |
Complies |
|
|
IR spectrum |
Complies |
||
|
Clarity and colour of solution |
Clear and not more than Y4BY4B4 |
＜BY4 |
|
|
Loss on drying |
Not more than 0.5% |
0.20% |
|
|
Sulphated ash |
Not more than 0.1% |
0.02% |
|
|
Related substances(HPLC) Impurity A Impurity G Single unknown impurity Total impurities |
Not more than 0.2% Not more than 0.2% Not more than 0. 15% Not more than 0.5% |
N.D 0.07% N.D 0.07% |
|
|
Residual solvents |
Acetone≤5000ppm Methanol≤500ppm |
1750ppm ＜1ppm |
|
|
Assay(potetiometic titration) Calculated on the dried basis |
Between 98.5% and 101.0% |
99.55% |
|
|
Conclusion |
Complies |
|
|
