A. Wiszkidenszky et al., Validated, stability-indicating semiquantitative purity test for allylestrenol drug substance and tablet by personal OPLC, J PL CHROM, 11(6), 1998, pp. 463-466
A semiquantitative OPLC purity test has been developed for allylestrenol bu
lk drug substance and a tablet containing allylestrenol as the active ingre
dient. Validation of this OPLC procedure was performed according to the sug
gestions of the corresponding ICH guideline for limit test, i,e. the specif
icity and detection Limit were determined, and the stability of the analyte
was checked.