发布日期:2020-09-04 10:05 浏览次数:
Item | Standard (BP2009/EP6.0/USP31) | Test Result |
Characters | Yellow crystalline powder, soluble in acetone and in ether. | Pass |
Identification | BP/EP: A, similar.B,C, Positive | Pass |
USP: A,C,D,E,F,Positive | Pass | |
B,Ultraviolet Absorption(380nm) | 98.30% | |
96.0%~104.0% | ||
Crystallinity | Meets the requirements | Pass |
PH | 1.8~2.8 | 2.5 |
Specific Optical Rotation | -240°~-255° | -248° |
Related Substances | 4-epiteracycline≤3.0% | 1.20% |
Anhydrotetracycline≤0.5% | 0.20% | |
4-epianhydrotetracycline≤0.5% | 0.02% | |
2-acetyl-2-decarbamoyltetracycline≤1.5% | 0.78% | |
Heavy Metals | Complies with limit test(50ppm) | Pass |
Loss on dry | ≤2.0% | 0.57% |
Sulphate Ash | ≤0.5% | 0.08% |
Assay(on dry) | BP/EP:95.0%~102.0% | 97.00% |
Potency | USP: ≥900ug/mg | 964ug/mg |
Residual solvents, 1-butanol | ≤5000ppm | Pass |
Residual solvents,Acetone | ≤5000ppm |
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