Oxytetracycline was the second of the broad-spectrum tetracycline group of antibiotics to be discovered.
White or almost white crystalline powder, No odor and bitter.Insoluble in water, freely soluble in chloroform, soluble in acetone or ethyl acetate, sparingly soluble in methanol of alcohol.
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TESTS |
USP Specifications |
Results |
|
Identification Tests (IR) |
Conforms to the reference spectrum |
Conforms |
|
Specific optical rotation |
-89°-95° |
-92° |
|
Crystallinity |
Should conform to requirements |
Conforms |
|
PH |
Between 7.5 and 10.0 |
8.7 |
|
Water |
≤2.0% |
0.92% |
|
Residue on ignition |
≤0.3% |
0.04% |
|
Residual Solvents |
Ethanol≤0.5% |
Not detected |
|
Heavy metals |
≤20ppm |
<20ppm |
|
Assay (HPLC, dried substance) |
9601040ug/mg |
981ug/mg |
|
Conclusion: Conforms to USP 28 specification for Clarithromycin |
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