Bisacodyl
;)
Phenol,4,4¢-(2-pyridinylmethylene)bis-,diacetate (ester).
4,4¢-(2-Pyridylmethylene)diphenol diacetate (ester) [603-50-9].
»Bisacodyl contains not less than 98.0percent and not more than 101.0percent of C22H19NO4,calculated on the dried basis.
Caution—Avoid inhalation and contact with the eyes,skin,and mucous membranes.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:Infrared Absorption á197Sñ—
Cell:
1.0mm.
Solution:
1in 200solution in chloroform,previously dried.
B:
Ultraviolet Absorption á197Uñ—
Solution:
20µg per mL.
Medium:
0.05Nhydrochloric acid.
Absorptivities at 263nm,calculated on the dried basis,do not differ by more than 3.0%.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.001%.
Assay—
Dissolve about 250mg of Bisacodyl,accurately weighed,in 70mLof glacial acetic acid,add 3drops of p-naphtholbenzein TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 36.14mg of C22H19NO4.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 262
Phone Number:1-301-816-8251