Details:
Appearance: A yellow powder,slightly soluble in water and in alcohol.It dissolves in solutions of slkali hydroxides and carbonates.
Identification A:The principal spot in the chromatogram obtained with the test solution is similar in position,colour and size to the principal spot in the chromatogram obtained with reference solution.
Identification B:To about 2mg add 5ml of sulphuric acid R.A deep blue colour develops which becomes bluish-green.Add the solution
to 2.5ml of water.The colour becomes brownish.
Identification C :Gives reaction of chlorides
PH :2.3 ~3.3(10mg/ml)
Specific optical rotation :-235.0°~-250.0°(2.5mg/ml)
Absorbance: ≤0.40(5mg/ml,460nm)
TC HCL(Anhydrous substance) :≤8.0%
Heavy metals: ≤50ppm
Water :≤2.0%
Sulfated ash :≤0.5%
CTC HCL(Anhydrous substance):≥89.5%
TC.HCL+CTC.HCL(Anhydrous substance):94.5%~102.0%
Related substance:
Impurity A: ≤4.0%
4-EPI-Isochlortetracycline: ≤0.8%
Demeclocycline :≤0.7%
Total of 4-EPI-Isochlortetracycline and demeclocycline:≤1.0%
2-Acetyl-2-decarboxamido-chlortetracycline:≤0.3%
Any other detectable impurity :≤0.1%
Formaldehyde :≤5ppm
Sulfate: ≤0.02%
Iron: ≤50ppm
Magnesium :≤50ppm
Zinc :≤10ppm
Proteins :≤0.1%
Crude fibre: ≤0.1%
Ethanol: ≤5000ppm
Methanol: ≤3000ppm