[Digoxin Reference Standard (Control 991) of National Institute of Health Sciences]

The raw material of digoxin was examined to prepare a "Digoxin Reference Standard". The analytical data obtained were: optical rotation, [alpha](20)D = + 11.7 degree; loss on drying, 0.008%, infrared spectrum, the same as that of the Digoxin Reference Standard (Control 807); high-performance liquid chromatography, several impurities detected and the total amount estimated to be about 0.31%, assay by spectrophotometry, 100.1%. Based on the above results, the candidate material was authorized as the Digoxin Reference Standard (Control 991) of the National Institute of Health Sciences.