Specification of Oxytetracycline HCL
Items |
Specifications |
Results |
Characters |
Yellow, Crystalline Powder |
Conform |
Solubility |
Freely soluble in water, Sparingly soluble in alcohol |
Conform |
Identification |
A: Thin-layer chromatography results |
Conforms |
B: Colour reaction with sulfuric acid |
Conforms |
C: Give reaction (a) of chlorides |
Conforms |
pH |
2.3~2.9 |
2.5 |
Specific optical rotation |
-188~-200 |
-196 |
Specific absorbance |
270~290 |
283 |
Light |
430nm |
≤0.50 |
0.18 |
490nm |
≤0.20 |
0.04 |
Related substances (%) |
Impurity A |
≤0.5 |
0.26 |
Impurity B |
≤2.0 |
0.47 |
Impurity C |
≤2.0 |
1.7 |
Total of impurities D. E and F |
≤2.0 |
0.2 |
Disregard limit |
≤0.1 |
conform |
Heavy metals (ppm) |
≤50 |
<50 |
Water(%) |
≤2.0 |
1.2 |
Sulfated ash(%) |
≤0.5 |
0.24 |
Assay (%) |
95.0~102.0 |
98.3 |
Methanol(ppm) |
≤3000 |
632 |
Conclusion |
The results can conforms with BP2018/EP9 |