Chemical Name:
1-(2-benzoyloxyethyl)-2-methyl-5-nitroimidazole
Trade Name:
Metronidazole Benzoate
Introduction:
Metronidazole, a powerful antiprotozoal and antibacterial drug, has a bitter taste, and it is not acceptable to some young patients. Metronidazole benzoate (benzoyl Metronidazole), the benzoyl ester of metronidazole, is tasteless and has also been widely used because of its greater palatability. Metronidazole benzoate is the benzoate ester of metronidazole which is obtained by condensation of benzoic acid and metronidazole. It is hydrolyzed before or during absorption through the gut wall so that only metronidazole can be detected in the circulation.
General Applications:
Metronidazole benzoate is used in the treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens ,particularly Bacteroides, Fragilis and other species of bacteroides and including other species for which metronidazole is bactericidal e.g. Fusobacteria, Eubacteria, Clostridia and anaerobic Cocci. It can be used in septicaemia, bacteraemia, brain abscess, peritonitis and post-operative wound infectiondue to anaerobic bacteria. Itis used also in prevention of acute dental infections (e.g. acute pericoronitis and acute apical infections), Trichomonas infections, Amoebiasis and Giardiasis.
| TEST | STANDARD | Unit | Ref |
| Appearance | White or slightly yellowish, crystalline powder or flakes. | – | BP 2017 |
| Solubility | Practically insoluble in water, freely soluble in methylene chloride, soluble in acetone, slightly soluble in alcohol. | – | BP 2017 |
| Melting point | 99 – 102 | Cº | BP 2017 |
| IR spectra | Spectrum obtained with standard Metronidazole benzoate. | – | BP 2017 |
| Appearance of solution | The solution is not more opalescent than reference suspension and not more intensely coloured than reference solution | – | BP 2017 |
| Acidity | Max 0.25 | ml NaOH
0.02 M |
BP 2017 |
| Related substances
|
—impurities A, B, C:not more than the area of the corresponding peak in the chromatogram obtained with reference solution (b) (0.1 per cent) | %wt | BP 2017 |
| -any other impurity :not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.1 per cent), | |||
| — total : not more than twice the area of the principal peak in the chromatogram obtained
with reference solution (a) (0.2 per cent) |
|||
| Heavy Metals | Max 20 | ppm | BP 2017 |
| Loss on drying | Max 0.5 | %wt | BP 2017 |
| Sulfated Ash | Max 0.1 | %wt | BP 2017 |
| Assay ( dried substance) | 98.5 – 101 | %wt | BP 2017 |
| Packing: | PE bags in Paper Drums |
| Net Weight: | 25 Kg’s |
| Gross Weight: | 40 Kg’s |
| No. Of Bags on Pallet: | 6 |
| No. Of Pallet in 20″ FCL: | 20 |
| Shelf Life: | 2 Years |
| IMCO Class: | Non-Imco |
Safety, Handling & Storage:
Full information on the safety, handling and storage of KECASs is available in the corresponding Material Safety Data Sheet (MSDS).
