ANALYSIS TEST
SPECIFICATIONS
RESULTS
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).
Color reaction with sulfuric acid
A yellow color develops
Reactionof chlorides
Positive reaction
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%
Any unspecified impurity
≤0.10%
0.03%
Total impurities
≤3.0%
2.51%
Assay(C22H25ClN2O8)
95.0%~102.0%
98.1%
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