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Home » Active Pharmaceuticals Ingredients » Losartan Potassium

Losartan Potassium

Product Name Losartan Potassium BP/EP/USP
Chemical Name 2 - Butyl - 4 - chloro - 1 - [[2' - (1H - tetrazol - 5 - yl)[1,1' - biphenyl] - 4 - yl] - methyl] - 1H - imidazole - 5 - methanol monopotassium salt
CAS Number 124750-99-8
Chemical Formula C22H23ClN6O • K ½C4H4O4
Molecular Mass 461.01 g/mol
Therapeutic Category Angiotensin II Receptor Antagonists

Specification of Losartan Potassium :

Test Specification
Description White to off-white powder
Solubility Freely soluble in water, soluble in isopropyl alcohol, slightly soluble in acetonitrile.
Identification
A. Infrared Absorption (In mineral oil)

B. Ultraviolet Absorption (10µg/ml in methanol)
C. Test for Potassium

The IR absorption spectrum of the test preparation, exhibits maxima and minima only at the same wavelength as that of a similar preparation of the Losartan potassium working Standard.
The UV Absorption spectra of the test solution and the standard solution exhibits maxima and minima at the same wavelengths. It meets requirements of the test for potassium
Water (by KFR, % w/w) NMT 0.50
Heavy Metals(%,w/w) NMT 0.001
Chromatographic Purity (By HPLC,%) Any individual impurity : NMT 0.20
Total Impurities : NMT 0.50
Assay (On anhydrous, solvent free basis, %) NLT 98.5 and NMT 101.0
Residual Solvents/OVI (by GC, ppm) Ethyl Acetate: : NMT 5000
Methylene Dichloride : NMT 600
Methanol : NMT 3000
Toluene : NMT 890
Triethyl amine : NMT 50
Isopropyl alcohol : NMT 2000
Chloroform : NMT 60

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