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. |
||
director: inspector: |