Bisacodyl
(bis ak' oh dil).
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361.39Phenol, 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.
USP Reference standards 
11
—
11—
USP Bisacodyl RS 
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Identification—
A:
Infrared Absorption 197S—
197S—
Cell:
1.0 mm.
Solution:
1 in 200 solution in chloroform, previously dried.
B:
Ultraviolet Absorption 197U—
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.
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.
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%.
281:
not more than 0.1%.
Heavy metals, Method II 231:
0.001%.
231:
0.001%.
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—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Elena Gonikberg, Ph.D.
Principal Scientific Liaison 1-301-816-8251 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2364
Pharmacopeial Forum: Volume No. 37(3)