China (Mainland) 
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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