Item

Specifications

Results

Identification

Complies

Complies

Crystallinity

Complies

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(As C23H27N3O7 on dried basis)

890ug/mg-950ug/mg

905ug/mg

Particle sizes

≥250ug(60mesh)

Less than 10%

5%

≥150ug(100mesh)

Less than40%

23%

≥38ug(400mesh)

Less than50%

42%

Conclusion

The results conforms with USP32 standards