| TESTS |
SPECIFICATIONS |
REFERENCE |
| |
| Description |
A white or almost white, crystalline powder.
A white fine powder. |
BP/IP
USP |
|
| |
| Solubility |
Practically insoluble in water, soluble in acetone, sparingly soluble in ethanol( 96 %) , It dissolves in dilute mineral acids. |
BP/USP/IP |
| |
| Identification |
(A) Melting Point is between 131°C and135°C.
|
BP/USP/IP |
| |
| (B) Examined between 220 nm & 350 nm, the solution shows maximum absorption at 248 nm. |
USP/IP |
| |
| (C) To comply with TLC test as per BP’ |
BP/IP |
| |
| (D) I.R. absorption spectrum of sample should be concordant with reference spectrum of Bisacodyl working reference standard |
USP/BP/IP |
| |
Related Substances
(By HPLC) |
Impurity A at 265 nm : NMT 0.1 %
Impurity B at 265 nm : NMT 0.1 %
Impurity C at 265 nm : NMT 0.5 %
Impurity D at 265 nm : NMT 0.2 %
Impurity E at 265 nm : NMT 0.5 %
Impurity F at 265 nm : NMT 0.3 %
Single Unknown Impurity : NMT 0.1 %
Total impurities : NMT 1.0 %
|
BP |
| |
| Acidity or Alkalinity |
Not more than 0.4 ml of 0.01M HCl is require to change the colour of the indicator to red |
BP/IP |
| |
| Heavy Metals |
Not more than 0.001 % W/V |
USP |
| |
| Loss on Drying |
Not more than 0.5 % w/w |
BP/USP/IP |
| |
| Residue on Ignition |
Not more than 0.1 % w/w |
USP |
| |
| Sulphated Ash |
Not more than 0.1% w/w |
BP/IP |
| |
| Assay (By Titration) |
NLT 98.0 % and NMT 101.0 % of C22H19NO4, on dried basis. |
BP/USP/IP |
