CAS number: 31431-39-7

Molecular formula: C16H13N3O3

molecular weight: 295.29

Chemical structure:

Sr No.TestSpecificationResult
1DescriptionWhite to slightly yellow powder amorphous Powder almost odourless. It shows
Slightly yellow powder Almost odourless. It shows
2SolubilityPractically insoluble in water, in dilute solution of mineral acid in alcohol, in ether and chloroform. freely soluble in formic acidComplies

a)     BY IRThe IR spectrum of the sample should be concordant with standard spectrum of the Mebendazole off white [OW] W.S.Complies

b)    By HPLCThe retention time of major peak of the sample Solution corresponds to that of the standard Solution [OW] WS as obtained in the assay.Complies
4Melting pointMelt at about 2900C2900C
5Loss on dryingDry at 1050C for 4 hrs , NMT 0.5 % w/w0.32 %
6Heavy metalsNot more than 0.002%Complies
7Related substance (HPLC)
2-amino mebendazoleNMT 0.25 %0.18 %
2-hydroxy mebendazoleNMT 0.25 %Not detected
2-Amino-1- methyl mebendazoleNMT 0.25 %Not detected
Mebendazole related compound DNMT 0.25 %Not detected
Ethyl mebendazoleNMT 0.25 %Not detected
Toluoyl mebendazoleNMT 0.25 %Not detected
Mebendazole dimerNMT 0.50 %Not detected
Unspecified impuritiesNMT 0.10 %0.060 %
Total impuritiesNMT 1.0 %0.31 %