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  • CAS No.: 124750-99-8
  • Type: Cardiovascular Agents, Other

Specifications

Freely soluble in water, soluble in isopropyl alcohol; slightly soluble in acetonitrile.

PRODUCT NAME : LOSARTAN POTASSIUM
TEST STANDARDS
DescriptionWhite to off-white powder.
SolubilityFreely 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 only at the same wavelength as that of a similar preparation of the corresponding USP Reference Standard.

The UV Absorption spectra of the test solution and standard solution exhibits maxima and minima at the same wavelengths.

It meets requirements of the test for potassium

Heavy metalsNot more than 0.001%
Water by KFNot more than 0.5%
Limit of cyclohexane and Isopropyl alcohol (By GC)Not more than 1000 PPM
Not more than 2000 PPM
Chromatographic Purity
(By HPLC)
Any individual impurity : Not more than 0.2%
Total Impurities : Not more than 0.5%
Assay (On anhydrous, solvent free basis)NLT 98.5% and NMT 101.0%
Residual SolventsAcetone : Not more than 5000 PPM
Ethyl Acetate : Not more than 5000 PPM
Methanol : Not more than 3000 PPM
Chloroform : Not more than 60 PPM
Toluene : Not more than 890 PPM
Acetonitrile : Not more than 410 PPM

 

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