Characters

Yellow,hygroscopic,crystalline powder.Freely soluble in water and in methanol,sparingly soluble in ethanol(96 per cent).It dissolves in solutions of alkali hydroxides and carbonates

Complies

Identification

HPLC

The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the  chromatogram obtained with reference  solution(a).

Complies

Color reaction with sulfuric acid

A yellow color develops

Complies

Reactionof chlorides

Positive reaction

Complies

PH

2.0 ~ 3.0

2.4

Absorbance

≤0.07

 0.01

Water

1.4%~2.8%

1.9%

Sulfated ash

≤0.4%

0.06%

Heavy metals

                ≤50ppm

  ＜50ppm

Ethanol

 4.3% ~ 6.0%

5.0%

ImpurityA(6-epidoxycycline)

 ≤2.0%

1.51%

Impurity F(2-Acetyl-2-decarboxyamidodoxycycline)

  ≤1.2%

0.93%

 Impurity B(Methacycline)

≤0.5%

0.01%

ImpurityC(4-epidoxycycline)

 ≤0.2%

0.01%

Any unspecified impurity

 ≤0.10%

0.03%

Total impurities

 ≤3.0%

2.51%

Assay(C22H25ClN2O8)

 95.0%~102.0%

98.1%