CAS number： 31431-39-7
Molecular formula： C16H13N3O3
molecular weight： 295.29
Chemical structure：
| Sr No. | Test | Specification | Result | |||
| 1 | Description | White to slightly yellow powder amorphous Powder almost odourless. It shows polymorphism | Slightly yellow powder Almost odourless. It shows polymorphism | |||
| 2 | Solubility | Practically insoluble in water, in dilute solution of mineral acid in alcohol, in ether and chloroform. freely soluble in formic acid | Complies | |||
| 3 | Identification | |||||
| a) BY IR | The IR spectrum of the sample should be concordant with standard spectrum of the Mebendazole off white [OW] W.S. | Complies | ||||
| b) By HPLC | The retention time of major peak of the sample Solution corresponds to that of the standard Solution [OW] WS as obtained in the assay. | Complies | ||||
| 4 | Melting point | Melt at about 2900C | 2900C | |||
| 5 | Loss on drying | Dry at 1050C for 4 hrs , NMT 0.5 % w/w | 0.32 % | |||
| 6 | Heavy metals | Not more than 0.002% | Complies | |||
| 7 | Related substance (HPLC) | |||||
| 2-amino mebendazole | NMT 0.25 % | 0.18 % | ||||
| 2-hydroxy mebendazole | NMT 0.25 % | Not detected | ||||
| 2-Amino-1- methyl mebendazole | NMT 0.25 % | Not detected | ||||
| Mebendazole related compound D | NMT 0.25 % | Not detected | ||||
| Ethyl mebendazole | NMT 0.25 % | Not detected | ||||
| Toluoyl mebendazole | NMT 0.25 % | Not detected | ||||
| Mebendazole dimer | NMT 0.50 % | Not detected | ||||
| Unspecified impurities | NMT 0.10 % | 0.060 % | ||||
| Total impurities | NMT 1.0 % | 0.31 % | ||||
