[Methyldigoxin Reference Standard (Control 881) of National Institute of Hygienic Sciences]

Methyldigoxin was tested for preparation of the "Methyldigoxin Reference Standard (Control 881)". Analytical data obtained were as follows: infrared spectrum 3456, 1738, 1086 cm-1; ultraviolet spectrum lambda max = 219 nm; absorbance E1cm1% (219 nm) = 193.1; water 0.99%; optical rotation [alpha]546.1(20) = +22.5 degrees; thin-layer chromatography and high-performance liquid chromatography indicates two impurities, respectively; quantitative analysis of acetone 3.87%; assay by spectrophotometry 100.3% against Digoxin Reference Standard (Control 802). On the basis of the above results, this material was authorized as the National Institute of the Hygienic Sciences Reference Standard (Control 881).