Bisacodyl USP XXV / B.P.

BISACODYL

MOLECULAR WEIGHT: C₂₂H₁₉NO₄

MOLECULAR FORMULA: 361.4

TEST	USP	BP / EP
CHARACTERS	------	A white or almost white crystalline powder
SOLUBILITY	-----	Practically insoluble in water. Soluble in acetone, sparingly soluble in ethanol(96%) it dissolves in dilute mineral acid
IDENTIFICATION MELTING POINT UV ABSORPTION INFRARED ABSORPTION TLC	Between 131OC and 135OC Absorptivities at 263 nm, calculated on dried basis, do not differ by more than 3.0% IR spectra concordant with reference sample	Between 131OC and 135OC Examined between 220 nm and 350 nm, the solution shows absorption maximum at 248 nm and a shoulder at about 290 nm IR spectra concordant with reference sample. The principal spot in the chromatogram obtained with test solution is similar in position and size to the principal spot in the chromatogram obtained with reference solution
ACIDITY OR ALKALINITY	-----	Not More than 0.4 ml of 0.01 M hydrochloric acid is required
RELATED SUBSTANCE IMP A,B IMP C,E IMP D IMP F UNSPECIFIED IMPURITIES TOTAL IMPURITIES DISREGARD IMPURITIES	-----	NMT 0.1% NMT 0.5% NMT 0.2% NMT 0.3% NMT 0.1% NMT 1.0% NMT 0.05%
LOSS ON DRYING	NMT 0.5%	NMT 0.5 % w/w
SULPHATED ASH	-----	NMT 0.10%
RESIDUE ON IGNITION	NMT 0.1 per cent,	------
HEAVY METALS	NMT 0.001%	------
ASSAY	Between 98.0% and 101.0% w/w	Between 98.0% and 101.0% w/w