| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Items | Standards | Results |
| Appearancewhite | white | Complies |
| Identification | By IR | Complies |
| The filtrate gives reaction of chlorides. | Complies | |
| Solubility | Sparingly soluble in water,slightly soluble in ethanol(96 percent),practically insoluble | Complies |
| pH | 3.9~4.6 | 4.47 |
| Clarity | Not more than 2 turbidity standard solution turbidity | Complies |
| Specific Optical Rotation | -125º~-138º | -130.12º |
| Water Content | ≤ 4.50% | 0.40% |
| Heavy Metals | ≤ 10ppm | Complies |
| Sulphated Ash | ≤ 0.10% | 0.03% |
| Residual Solvents | Chloride: ≤ 600ppm | ND |
| Ethanol: ≤ 5000ppm | 71ppm | |
| Acetic Acid: ≤ 5000ppm | 27ppm | |
| Related Substance | Impurity A: ≤0.10% | 0.04% |
| Impurity B: ≤0.10% | ND | |
| Impurity C: ≤0.10% | ND | |
| Impurity D: ≤0.10% | ND | |
| Impurity E: ≤0.10% | ND | |
| Unspecified impurities: ≤0.10% | 0.05% | |
| Total impurities: ≤0.30% | 0.10% | |
| Assay (on the anhydrous basis) | 98.0%~102.0% | 99.88% |
| Reference Standard | BP Standard | |
| Conclusion | The product complied to BP standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
Moxifloxacin is a broad-spectrum 8-methoxy fluoroquinolone antibacterial agent with antibacterial activity. Moxifloxacin has shown broad spectrum antibacterial activity in vitro against Gram-positive, Gram-negative, anaerobic, acid-fast, and atypical microorganisms such as Mycoplasma, Chlamydia, and Legionella. The mechanism of antibacterial action is to interfere with and topoisomerase. Topoisomerases are key enzymes that control DNA topology and play a role in DNA replication, repair and transcription. The bactericidal curve showed that moxifloxacin had a concentration dependent bactericidal activity. The minimum bactericidal concentration and the minimum inhibitory concentration were basically the same. Moxifloxacin is also effective against bacteria resistant to β-lactam and macrolide antibiotics. The high activity of moxifloxacin in vivo was confirmed by experimental animal models of infection.
| Items | Requirements | Results |
| Physical & Chemical | ||
| Appearance | White powder | Conform |
| Odor | Characteristic | Characteristic |
| Particle Size | 98% pass 80mesh | Complies |
| Loss on Drying | ≤5.0% | 3.65% |
| Ash | ≤5.0% | 1.96% |
| Solvent Residue | Meet USP standard | Complies |
| Pesticide Residue | Meet USP standard | Complies |
| Heavy Metal | ||
| Lead (Pb) | ≤2.0ppm | Conform |
| (As) | ≤1.0ppm | Conform |
| (Cd) | ≤1.0ppm | Conform |
| (Hg) | ≤0.1ppm | Conform |
| Microorganism | ||
| Total Plate Count | ≤1000cfu/g | Conform |
| Yeasts and Molds | ≤100cfu/g | Conform |
| Saimonella | Negative/25g | Conform |
| E.coli | Negative | Conform |
| Assay | 98% | 98.5% |
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