Test

Specifications

Batch I

Batch II

Assay

95% - 105% asper BP

106.5%

105.7%

90% - 120% asper USP

4-epidoxycycline

<0.5%*

0.14%

0.13%

Metacycline

<2%

0.66%

0.15%

6-epidoxycycline

<2%

1.15%

1.12%

Maximum unknown impurity

<0.5%

ND**

ND**

Total impurities

N/A**

1.95%

1.39%