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发表于 2016-1-14 15:09:53
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Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11—
USP Bisacodyl RS.
Identification—
A: Infrared Absorption 197S—
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%.
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.
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