|
Items
|
Specifications
|
Results
|
|
Characteristic
|
Off-white to yellow powder
|
Comply
|
|
Infrared Absorption(197K)
|
Comply
|
Comply
|
|
HPLC
|
Comply
|
Comply
|
|
Loss on drying
|
≤5.0%
|
4.0%
|
|
Individual related compoubd
|
≤3.0%
|
2.3%
|
|
Total related compounds
|
≤10.0%
|
8.0%
|
|
PH
|
4.5~7.5
|
7.1
|
|
Assay
A. Tilmicosin
B.Cis-isomer
C.Trans-isomer
|
A.≥75.0%
B.82.0%~88.0%
C.12.0%~18.0%
|
A.76.5%
B.83.7%
C.16.3%
|
