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Metronidazole (MNZ), is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. It is the drug of choice for a first episode of mild-to-moderate Clostridium difficile colitis.Metronidazole is available by mouth, as a cream, and intravenously.
Specification:
|
ITEMS |
STANDARDS |
RESULTS |
|
|
Appearance |
a white or yellowish crystalline powder |
COMPLY |
|
|
Solubility |
Slightly solube in water,in acetone,in alcohol and in methylene,chloride |
COMPLY |
|
|
c),a),b) Identification c),a),b) |
c) infrared a) Melting point 159-163°C b) Specific absorbance 365-395 |
c) COMPLY a) 160.6-160.9°C b) 378 |
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|
Loss on drying |
0.5% MAX |
0.17% |
|
|
Residue on ignition |
0.1% MAX |
0.05% |
|
|
Heavy Metal |
20PPM MAX |
<20PPM |
|
|
Particle size |
40-80 MESH |
COMPLY |
|
|
Residual solvents |
Ethylene oxide (LOD 0.15ppm) Formic acid (LOD 124ppm) |
Not detected. Not detected |
|
|
Appearance of solution |
SUSPENSIONâ…¡ AND SOLUTION GY6 |
COMPLY |
|
|
Related substances: |
1)Impurity |
0.1%MAX |
0.02% |
|
2)Total impurity |
0.2%MAX |
0.06% |
|
|
3)Disregard limited |
0.01% MAX |
PASS |
|
|
Assay |
99.0%-101.0% C6H9N3O3 |
99.4%C6H9N3O3 |
|
|
Conclusion: comply with the requirement of BP2010standard. |
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Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
