Oxytetracycline Hydrochloride EP

Test Items

Specifiation

Description

Yellow crystalline powder

Identification

a)   TLC results

b)   Color reaction with sulphuric acid

c)   Reaction of chlorides

pH Value (1% w/v)

Between 2.3 and 2.9

Absorbance (at 353nm, pH2.0)

Between 270 and 290

Specific optical rotation

Between -188 and -200

Heavy metals

Not more than 50ppm

Light absorbing impurities

Absorption at 430nm shall not be more than 0.50

Absorption at 490nm shall not be more than 0.20

Sulfated ash

Not more than 0.5%

Water content

Not more than 2.0%

Assay(calculated on

anhydrous product)

Between 95.0% and 102.0%

Related substance

  Impurity A

  Impurity B

  Impurity C

  Total of impurities D,E,F

Not more than 0.5%

Not more than 2.0%

Not more than 2.0%

Not more than 2.0%