Propranolol hydrochloride

Details:

COMPLY WITH BP2009 PRODUCT NAME PROPRANOLOL HYDROCHLORIDE BP 2009EXPIRY 5 yearsCAS NO.TESTSSPECIFICATIONSRESULTSCHARACTERSAPPEARANCEA WHITE OR ALMOST WHITE POWDER.CONFORMSOLUBILITYSOLUBLE IN WATER AND IN ETHANOL (96%).CONFORMIDENTIFICATIONAMELTING POINT 163°C TO 166°C163.5 ~ 164.0°CBEXAMINE BY INFRARED ABSORPTION SPECTROPHOTOMETRY, COMPARING WITH THE SPECTRUM OBTAINED WITH PROPRANOLOL HYDROCHLORIDE CRS.CONFORMCEXAMINE BY THIN-LAYER CHROMATOGRAPHY. THE PRINCIPAL SPOT IN THE CHROMATOGRAM OBTAINED WITH THE TEST SOLUTION IS SIMILAR IN POSITION, COLOUR AND SIZE TO THE PRINCIPAL SPOT IN THE CHROMATOGRAM OBTAINED WITH THE REFERENCE SOLUTION.CONFORMDIT GIVES REACTION (A) OF CHLORIDES.CONFORMTESTSAPPEARANCE OFSOLUTIONTHE SOLUTION IS CLEAR AND NOT MORE INTENSELY COLOURED THAN INTENSITY 6 OF THE RANGE OF REFERENCE SOLUTIONS OF THE MOST APPROPRIATE COLOUR.CONFORMACIDITY ORALKALINITYADD 0.2 ml OF METHYL RED SOLUTION R AND 0.2 ml OF 0.01 M HYDROCHLORIC ACID. THE SOLUTION IS RED. ADD 0.4 ml OF 0.01 M SODIUM HYDROXIDE. THE SOLUTION IS YELLOW.CONFORMRELATED SUBSTANCESANY IMPURITY NMT 0.1%.0.06%THE SUM OF ALL IMPURITIES NMT 0.4%.0.25%HEAVY METALSNMT 20ppm.CONFORMLOSS ON DRYINGNMT 0.5%.0.23%SULPHATED ASHNMT 0.1%.0.06%RESIDUAL SOLVENTSA. ETHANOL NMT 5000ppm.CONFORMB. XYLENE NMT 2170ppm.CONFORMASSAY99.0% ~ 101.0%99.4%CONCLUSION CONFORM TO BP2009