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Bisacodyl

Bulk Active : Bisacodyl
MOLECULAR FORMULA : C22H19NO4
MOLECULAR WEIGHT : 361.39
Pharmacologic Activity : Laxative
CAS No : 603-50-9
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)

TEST USP 36 BP 2013/EP 7.4
     
CHARACTERS White to off-white, crystalline powder A white or almost white crystalline powder
     
SOLUBILITY Soluble in chloroform and in benzene; sparingly soluble in alcohol and in methanol; slightly soluble in ether; practically insoluble in water 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



TEST B(USP)

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IR spectra concordant with reference sample

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The retention time of the major peak in the Sample solution corresponds to that of the Standard stock solution, as obtained under Organic Impurities
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.
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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

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ACIDITY OR ALKALINITY ----- Not More than 0.4 ml of 0.01 M hydrochloric acid is required
     
RELATED SUBSTANCE
IMP A
IMP B
IMP C
Specified unidentified
Impurity 1
IMP D
IMP E
IMP F
Specified unidentified
Impurity 2
UNSPECIFIED IMPURITIES
TOTAL IMPURITIES
NMT 0.15%
NMT 0.15%
NMT 0.05%
NMT 0.20%
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NMT 0.5%
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NMT 0.3%
NMT 0.10%
NMT1.00%

NMT 0.1%
NMT 0.1%
NMT 0.5%
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NMT 0.2%
NMT 0.5%
NMT 0.10%
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NMT 0.1%
NMT 1.0%

     
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