Product specification
| Parameter | Specification |
|---|---|
| Characteristics | (methyl [5-[4-(formylamino)benzoyl]-1H-benzimidazol-2-yl]carbamate) Impurity B (2-amino-1H-benzimidazol-5-yl)(4-fluorophenyl)methanone) Impurity C ((4-fluorophenyl)(2-hydroxy-1H-benzimidazol-5-yl)methanone) Impurity D ((1H-benzimidazol-5-yl)(4-fluorophenyl)methanone) Impurity E (methyl [5-(2-fluorobenzoyl)-1H-benzimidazol-2-yl]carbamate) Impurity F (methyl [5-(4-fluorobenzoyl)-1-methyl-1H-benzimidazol-2-yl]carbamate) Impurity G (methyl [5-[4-(1-methylethoxy)benzoyl]-1H-benzimidazol-2-yl]carbamate) Any other impurity with a relative retention between 1.2 and 1.3 Total impurities HAZARDOUS IDENTIFICATION STORAGE White or almost white powder. Practically insoluble in water, in alcohol and in methylene chloride. It shows polymorphism. 99.0% to 101.0% ( dried substance) Conforms to Ph. Eur. tests Not more than 0.5% Not more than 0.1% Maximum 0.25% Maximum 0.25% Maximum 0.25% Maximum 0.25% Maximum 0.25% Maximum 0.50% |
| Assay (content) | Maximum 0.25% |
| Identification | Maximum 0.25% |
| Loss on drying | Maximum 1.50% |
| Sulphated ash | Non-hazardous chemical |
| Impurity A | Keep container tightly closed in a cool and dry place and protected from light. Protect from contamination by foreign substances. |