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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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