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 % |