DATONG TONGXING ANTIBIOTIC CO.,LTD.
 
 
 
 
 

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

 

 

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