Tests

BP2000

USP25

EPIV

Characteristic

  Yellow crystalline powder

Identification

POSITIVE

Specific optical rotation [a] 20D

-203--216

-203--216

Acidity or alkalinity

4.5-7.5

4.5-7.0

4.5-7.5

Loss on drying (%)

4.0-8.0

6.0-9.0

4.0-8.0

Light absorption(353nm)

290-310

Complies

290-310

Light absorption impurities(430nm)

≤ 0.25

≤ 0.25

Light absorption impurities(490nm)

≤ 0.20

≤ 0.20

Ash(%)

≤ 0.5

≤ 0.5

Heavy metal(ppm)

≤ 50

≤ 50

Related substance

4-epioxytetracycline Tetracycline HCL

≤ 0.5%≤ 2.0%

≤ 0.5%≤ 2.0%

Other substance 

Complies

Complies

HPLC Assay

95.0%-100.5%

≥ 83.2%

95.0%-100.5%