Name of product: Tetracycline Hydrochloride EP9

Items

Specifications

Characters

Yellow, crystalline powder. Soluble in water, slightly soluble in ethanol (96 percent), practically insoluble in acetone, It dissolves in solutions of alkaili hydroxides and carbonates, solutions in water become turbid on standing, owing to the precipitation of Tetracycline.

Identification

A.TLC

Conform to the reference.

B. Color

Reaction To about 2mg add 5ml of sulphuric add the solution to 2.5ml of water. The color becomes yellow.

C. Chlorides

Reaction of chlorides.

Acidity (pH)

1.8-2.8

Specific optical rotation (dried substance)

-240 to -255

Loss on drying

≤2.0%

Sulphated ash

≤0.5%

4-Epitetracycline

≤3.0%

4-Epianhydrotetracycline

≤0.5%

Anhydrotetracycline

≤1.5%

2-Acetyl-2-decarbamoyltetracycline

≤0.5%

Chlortetracycline hydrochloride

≤0.5%

Any other impurity

≤0.05%

Assay (on dry basis)

≤95.0%-102.0%

Residual solvents

Acetone (G.C.)

≤ 100ppm

N-butanol (G.C.)

≤ 3000ppm