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 |
|
|
|