Keywords

• Levofloxacin Impurity A(Hydrochloride)
• (S)-9-fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid hydrochloride
• C17H18FN3O4.HCl

Quick Details

• ProName: Levofloxacin Impurity A(Hydrochloride)
• CasNo: 2254176-11-7
• Molecular Formula: C17H18FN3O4.HCl
• Appearance: solid
• Application: for drug impurities, for drug standard...
• DeliveryTime: 1-2 weeks
• PackAge: 10mg/25mg/50mg/100mg/1000mg/5000mg
• Port: SHENZHEN or SHANGHAI
• ProductionCapacity: 5000 Metric Ton/Year
• Purity: 95%+ or 98%+
• Storage: short-term storage normal temperature....
• Transportation: express and sea transport and air frei...
• LimitNum: 25 Milligram
• Moisture Content: within 3%
• Impurity: within 5%

Superiority

Advantages

• Ultra-High Purity：Confirmed by HPLC (≥99.0%) and verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing a reliable standard for Levofloxacin impurity analysis.
• Exceptional Stability：Stable for 36 months under -20℃ light-protected and sealed storage conditions. The degradation rate is less than 0.3% within 6 months in methanol - water mixture, ensuring excellent repeatability and stability of experimental data.

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Details

Levofloxacin Impurity A(Hydrochloride)

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Product Information

• Product Code：L004001A

• English Name：Levofloxacin Impurity A(Hydrochloride)

• English Alias：(S)-9-fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid hydrochloride

• CAS No.：2254176-11-7

• Molecular Formula：C17H18FN3O4.HCl

• Molecular Weight：347.34 36.46

Advantages

• Ultra-High Purity：Confirmed by HPLC (≥99.0%) and verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing a reliable standard for Levofloxacin impurity analysis.

• Exceptional Stability：Stable for 36 months under -20℃ light-protected and sealed storage conditions. The degradation rate is less than 0.3% within 6 months in methanol - water mixture, ensuring excellent repeatability and stability of experimental data.

Applications

• Quality Control Core：Used for UPLC-MS/MS detection of Impurity A in Levofloxacin API and formulations. Strictly comply with ICH Q3A standards (single impurity limit ≤0.1%) to accurately control impurity content and ensure drug quality and safety.

• Process Optimization Key：Monitor the formation pathway of this impurity during Levofloxacin synthesis. By adjusting parameters such as piperazination reaction temperature (e.g., 50 - 60℃), reaction time, and reactant ratio, the generation of impurities can be reduced by more than 35%.

• Method Validation Foundation：As a standard for developing impurity detection methods, it can verify the resolution (≥3.0) and limit of detection (0.01 ng/mL) of UPLC, ensuring the sensitivity and accuracy of the detection method.

Background Description

Levofloxacin, a broad-spectrum quinolone antibiotic, exerts antibacterial effects by inhibiting bacterial DNA gyrase and topoisomerase IV and is widely used in the treatment of respiratory, urinary tract, and other infectious diseases. Impurity A, a key process-related impurity in its synthesis, may originate from side reactions during the construction of the oxazinoquinoline ring or piperazine substitution. Its fluorine atom, piperazine group, and carboxyl group may affect the drug's antibacterial activity, metabolic stability, and safety. Given that the control of impurities in antibiotics is directly related to clinical efficacy and drug safety, the study of this impurity is an important part of ensuring drug quality.

Research Status

• Cutting-Edge Detection Technology：UPLC-MS/MS technology, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile, achieves impurity separation within 7 minutes, with a detection limit as low as 0.003 ng/mL for high-precision trace impurity detection.

• In-Depth Formation Mechanism：Studies show that this impurity is formed by the reaction of (S)-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid with piperazine under the action of an acidic catalyst. Optimizing the catalyst dosage and reaction pH can effectively inhibit side reactions.

• Rigorous Safety Evaluation：In vitro cytotoxicity experiments show that the IC?? of this impurity against Vero cells is 192.5 μM (Levofloxacin IC?? = 10.8 μM). Although the toxicity is lower than that of the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being carried out to systematically study its degradation characteristics under high temperature, high humidity, and light conditions.