|
Product name
|
Losartan Potassium
|
|
Molecular Formula
|
C22H23ClKN6O
|
|
Molecular Weight
|
462.01
|
|
CAS No.
|
124750-99-8
|
|
Quality Standard
|
98.5% up, USP32,
medical grade
|
|
Appearance
|
White powder
|
|
COA of Losartan Potassium
|
|
ITEMS
|
SPECIFICATION
|
RESULTS
|
|
APPEARANCE
|
A WHITE TO OFF-WHITE POWDER.
|
WHITE CRYSTALLINE POWDER
|
|
IDENTIFICATION
|
(1) INFRARED ABSORPTION
MUST SIMILAR TO REFERENCE STANDARD
|
CONFORMS
|
|
(2) ULTRAVIOLET ABSORPTION
MUST SIMILAR TO REFERENCE STANDARD
|
CONFORMS
|
|
3)TEST FOR POTASSIUM MUST BE POSITIVE
|
POSITIVE
|
|
WATER
|
NOT MORE THAN 0.5%
|
0.2%
|
|
HEAVY METALS
|
NOT MORE THAN 0.001%
|
CONFORMS
|
|
CHROMATOGRAPHIC PURITY
|
ANY INDIVIDUAL IMPURITY:NMT 0.2%
|
0.02%
|
|
TOTAL IMPURTIES:NMT 0.5%
|
0.10%
|
|
RESIDUAL SOLVENTS
CYCLOHEXANE
ISOPROPANOL ALCOHOL
|
NMT 0.1%
NMT 0.2%
|
0.010%
0.03%
|
|
ASSAY (HPLC)
|
98.5%-101.0%
|
99.4%
|
|
PARTICLE SIZE
|
90% LESS THAN 38 MICRONS
|
29.8 MICRONS
|
|
CONCLUSION
|
COMPLIES WITH USP32 AND REQUIREMENT OF ADDITIONAL
ITMES.
|
Losartan
Potassium is mainly used
for treatment of high blood pressure.
