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Bisacodyl
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C22H19NO4 361.39

Phenol, 4,4¢-(2-pyridinylmethylene)bis-, diacetate (ester).
4,4¢-(2-Pyridylmethylene)diphenol diacetate (ester) [603-50-9].
» Bisacodyl contains not less than 98.0 percent and not more than 101.0 percent 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—
Cell: 1.0 mm.
Solution: 1 in 200 solution in chloroform, previously dried.
B: Ultraviolet Absorption 197U—
Solution: 20 µg per mL.
Medium: 0.05 N hydrochloric acid.
Absorptivities at 263 nm, calculated on the dried basis, do not differ by more than 3.0%.
Melting range 741: between 131 and 135.
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.001%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 250 mg of Bisacodyl, accurately weighed, in 70 mL of glacial acetic acid, add 3 drops of p-naphtholbenzein TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 36.14 mg of C22H19NO4.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 286
Phone Number : 1-301-816-8251