DEFINITION
5-[(2R)-2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide hydrochloride.
Content
98.5 per cent to 1 01 .0 per cent (dried substance).
CHARACTERS
Appearance
White or almost white powder.
Solubility
Slightly soluble in water, freely soluble in formic acid, slightly soluble in anhydrous ethanol.
mp
About 230 °C.

IDENTIFICATION

Carry out either tests A, C, D or tests A, B, D.
A. Infrared absorption spectrophotometry (2.2.24).
Comparison tamsulosin hydrochloride CRS.
B. Specific optical rotation (2.2.7): - 1 7.5 to - 20.5 (dried substance).
Dissolve with heating 0.15 g in water R and dilute to 20.0 mL with the same solvent.
C. Enantiomeric purity (see Tests).
D. Dissolve with heating 0.75 g in water R and dilute to 1 00.0 mL with the same solvent. Take 5 mL of
the solution and cool in an ice-bath. Add 3 mL of dilute nitric acid R and shake. Allow to stand at room
temperature for 30 min and filter. The filtrate gives reaction (a) of chlorides (2.3.1)