CERTIFICATE OF ANALYSIS CLOMIFENE CITRATE Batch No.: 20170904 QUANTITY TESTSTANDARD
10KG USP XXXVI
MANUFACTURE DATE
SEP.04.2017
EXPIRATION DATE
SEP.03.2019
TEST Apearance
SPECIFICATION White or off-white powder
RESULT Conforms
Identification
UV conform
Conforms
Organic nitrogenous bases
Conforms
Conforms
Citrate
Conforms
Conforms
Solution
Water Heavy metals
Related impurities
Slightly soluble in water and in chloroform freely soluble in methanol sparingly soluble in alcohol insoluble in ether Not more than 1.0% Not more than 0.002% Related compound A : Not more than 2.0% Individual: Not more than 0.5% Total impurities : not more than 2.0%
（Z）isomer
Between 30% to 50%
Organic volatile impurities
Ethonol : not more than 5000PPM
Assay
Between 98.0% to 102.0%
Conforms 0.54% Conforms 0.84% 0.32% 1.4% 33% 800PPM 98.8%