Oxytetracycline Base EP

Test Items

Specification

Description

Yellow crystalline powder

Identification

a)     TLC results

b)     Colour reaction with sulphuric acid

c)     Reaction of chlorides

pH Value (1% w/v)

Between 4.5 and 7.5

Absorbance (at 353nm, pH2.0)

Between 290 and 310

Specific optical rotation

Between -203 and -216

Heavy metals

Not more than 50ppm

Light absorbing impurities

Absorption at 430nm shall not be more than 0.25

Absorption at 490nm shall not be more than 0.20

Sulfated ash

Not more than 0.5%

Water content

Between 6.0% and 9.0%

HPLC Assay(calculated on

anhydrous product)

Between 95.0% and 102.0%

Related substance

Content of impurity peak meets the requirements.