pure metronidazole
|
ITEMS |
STANDARDS |
RESULTS |
|
Identification |
A:IR B:UV |
COMPLY |
|
Meltion point |
159-163°C |
160.3-160.6°C |
|
Loss on drying |
0.5% MAX |
0.19% |
|
Residue on igniton |
0.1% MAX |
0.04% |
|
Appearance of solution |
SUSPENSIONⅡ AND SOLUTION GY6 |
COMPLY |
|
Tapped density |
≥0.7 |
Complies |
|
Heavy Metal |
20PPM MAX |
<20PPM |
|
Microorganism test |
Total barcterium<1000UFC/G Fungi and Mould<100UFC/G |
COMPLY |
|
BACTERIAL ENDOTOXINS(EU/mg) |
NOT MORE THAN 0.35 |
COMPLIES |
|
Related substances |
Impurity:0.1MAX Total impurity:0.2MAX |
0.054% 0.090% |
|
Particle size |
40-80MESH |
COMPLY |
|
Specific absorbance |
365-395 |
376 |
|
Assay |
99.0%-101.0% C6H9N3O3 |
99.62%C6H9N3O3 |
|
Conclusion: comply with the requirement of EP6 standard. |
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|
Director: Inspector: |
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