oxytetracycline dihyclorate
|
Product intro.
|
|
Name
|
Packing
|
Annual output
|
Certificate approval number
|
|
Oxytetracycline dihyclorate
|
25Kg/bag
|
4000tons
|
H14020081
|
|
|
Quality standards for oxytetracycline dihyclorate
|
| |
|
Based on
Standards
items
|
EP8.0 BP2013 |
USP36 |
| Appearance |
Yellow crystalline powder |
Yellow crystalline powder |
| Identification |
A、TLC |
As required |
-- |
| B、Sulfuric acid reaction |
As required |
As required |
| C、Nitric acid reaction |
As required |
-- |
| crystalline |
-- |
As required |
| pH |
4.5-7.5 |
4.5-7.0 |
| Specific optical rotation |
-203° - -216° |
-- |
| UV absorption at 353nm |
290-310 |
96.0%-104.0% |
| UV absorption of impurity |
430nm |
≤0.25 |
-- |
| 490nm |
≤0.20 |
-- |
| Related substances |
4-epoxytetracycline |
≤0.5% |
-- |
| Tetracycline hydrochloride |
≤2.0% |
-- |
| Main peak tailing |
≤2.0% |
-- |
| Other |
≤0.1% |
-- |
| Heavy metal |
≤50ppm |
-- |
| Water content |
6.0%-9.0% |
6.0%-9.0% |
| Ash |
≤0.5% |
-- |
| Assay |
95.0%-100.5% |
≤832ug/mg |
|
|
|
