
Molecular Formula: C22H24N2O8.HCl
Molecular Weight: 496.90
Standard: BP2009/EP6.0/USP31,
Appearance: yellowish crystalline powder,
Usage: type of broad-spectrum antibiotics. It can be used for bacillary dysentery (bacillary dysentery), trachoma, whooping cough, purulent meningitis, peritonitis, pneumonia, osteomyelitis. Scarlet fever, typhus, urinary tract infections, skin infections, otitis media, amoebic dysentery, biliary tract infections, intestinal infections, sepsis and so on. It can also be used in penicillin-resistant strains of infections, penicillin allergy.
Certificate of Analysis,
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 |