|
Item |
Specifications |
Results |
|
Identification |
Complies |
Complies |
|
Appearance |
White crystalline powder |
Complies |
|
Acidity |
PH3.5-4.5 |
3.9 |
|
Water |
4.3%-8.0% |
6.8% |
|
Residue on ignition |
Not more than 0.15% |
0.12% |
|
Heavy metals |
Not more than0.005% |
<0.005% |
|
Chromatographic purity |
||
|
Epi-minocycline |
Not more than1.2% |
0.6% |
|
Max impurity |
Not more than1.2% |
0.6% |
|
Total impurities |
Not more than2.0% |
0.9% |
|
Assay |
890ug/mg-950ug/mg |
905ug/mg |
|
Particle sizes |
||
|
≥250ug(60mesh) |
Less than 10% |
5% |
|
≥150ug(100mesh) |
Less than40% |
23% |
|
≥38ug(400mesh) |
Less than50% |
42% |
