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Characteristic:This product is a yellow crystalline powder; no smell, taste, slightly bitter flavor; slight cited moist; in sunlight colors darken, dissolved easily in damage in the alkaline failure. This product is soluble in water, slightly soluble in ethanol, insoluble in chloroform or ether. Than the rotation to take this product, precision that set, add hydrochloric acid soluble (9-1000) dissolved and diluted to 10mg per 1ml of solution containing, dark place 1 hour, according to the determination of optical rotation of -188 degrees to -200 degrees.
Solubility:
Easily soluble in water, slightly soluble ethanol, sparingly soluble in alcohol, insoluble in chloroform or aether.
Test Date2009.06.18
Expiry Date2013.05
Item | Standard | Result |
Description | Yellow crystalline powder, freely soluble in water, sparingly soluble in alcohol | |
Identification | TLC Reaction of color Reaction of chloride | Conforms |
PH | 2.3~2.9 | 2.5 |
Specific optical Rotation | -188°~ -200° | -193.0° |
Specification absorbance | 270 ~ 290 | 279 |
Heavy metals | <50ppm | <0ppm |
Light absorbing impurities | 1) Absorbance at 430nm shall not be more than 0.50 2)Absorbance at 490nm shall not be more than 0.200.19 | |
Related substances | Impurity A≤0.5% Impurity B≤2.0% Impurity C≤2.0% Impurity D,E,F≤2.0% Disregard limit≤0.1% | 0.5% 0.3% 0.3% No detected 0.3% |
Sulfated ash | ≤0.5% | 0.08% |
Water | ≤2.0% | 0.5% |
assay | 95.0%~102.0% | 97.4% |
Residual methanol | ≤3000ppm | 1377ppm |
Pharmacological:Is a broad-spectrum antibiotic, its antibacterial spectrum, antibacterial principles and application of tetracycline basically the same. Many Rickettsia, Mycoplasma, Chlamydia, spirochetes, amebic protozoa and some parasites are also sensitive to this product. Enterococcus its resistance. Others such as Actinomyces spp, Bacillus anthracis, Listeria monocytogenes bacteria, Clostridium, slave card spp, Vibrio, Brucella spp, Campylobacter, Yersinia bacteria sensitive to this product. The product of the gonococcal and meningococcal certain degree of antibacterial activity, but resistant to penicillin are also resistant Neisseria gonorrhoeae to oxytetracycline. Over the years due to extensive use of tetracycline, oxytetracycline resistance of common pathogenic bacteria in the clinical phenomenon of serious, including Staphylococcus aureus and other Gram-positive bacteria and the majority of Gram-negative bacilli. Tetracycline antibiotic cross-resistance between different species. This product mechanism is that the drug can specifically with bacterial 30S ribosomal subunit combination of A-position, inhibit the growth and impact of the peptide chain bacterial protein synthesis. This product is on the gastro-intestinal infections, including amoebic dysentery, slightly stronger than the effect of tetracycline. And tetracycline are closely cross-resistance.
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package:25kg/drum
Oxytetracycline HCL