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枸櫞酸氯米芬
CLOMIFENE CITRATE
Batch No.: 20180928
|
數量 QUANTITY |
25KG |
生產日期 MANUFACTURE DATE |
2018.09.28 Sep.28.2018 |
|
檢驗依據 TESTSTANDARD |
《美國藥典》36版 USP XXXVI |
有效日期 EXPIRATION DATE |
2020.09.27 Sep.27.2020 |
項 目 標 準 結 果
TEST SPECIFICATION RESULT
|
Apearance |
White or off-white powder |
Conforms |
|
Identification |
UV conform |
Conforms |
|
Organic nitrogenous bases |
Conforms |
Conforms |
|
Citrate |
Conforms |
Conforms |
|
Solution |
Slightly soluble in water and in chloroform freely soluble in methanol sparingly soluble in alcohol insoluble in ether |
Conforms |
|
Water |
Not more than 1.0% |
0.33% |
|
Heavy metals |
Not more than 0.002% |
Conforms |
|
Related impurities |
Related compound A : Not more than 2.0% |
0.42% |
|
Individual: Not more than 0.5% |
0.35% |
|
|
Total impurities : not more than 2.0% |
1.55% |
|
|
（Z）isomer |
Between 30% to 50%
|
31.2% |
|
Organic volatile impurities |
Ethonol : not more than 5000PPM |
800PPM |
|
Assay |
Between 98.0% to 102.0% |
98.8% |
結論： 本品按《美國藥典》36版標準檢驗，結果符合規定。
