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Bulk Active : Bisacodyl
MOLECULAR FORMULA : C22H19NO4
MOLECULAR WEIGHT : 361.39
Pharmacologic Activity :
Laxative
CAS No : 603-50-9
Specifications : JP
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) |
------ ------ IR spectra concordant with reference sample ------ 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. ------ 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 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% ----- NMT 0.5% ----- NMT 0.3% NMT 0.10% NMT1.00% |
NMT 0.1% NMT 0.1% NMT 0.5% ----- NMT 0.2% NMT 0.5% NMT 0.10% ----- 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 |
