Moxifloxacin Hydrochloride is a fourth-generation synthetic fluoroquinolone active pharmaceutical ingredient. It functions via the inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, interrupting DNA replication, transcription, repair, and recombination processes. Produced under strict current Good Manufacturing Practice (cGMP) guidelines, this small molecule API serves as the active core for formulating finished pharmaceutical products targeting respiratory tract infections, skin structures, and intra-abdominal pathogens.
Product Information
|
Parameter |
Specification Details |
|
International Nonproprietary Name (INN) |
Moxifloxacin Hydrochloride |
|
CAS Registry Number |
186826-86-8 |
|
Chemical Name |
1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid hydrochloride |
|
Structural Formula Classification |
Fluoroquinolone derivative |
|
Physical Description |
Slightly yellow to yellow crystalline powder |
|
Solubility Profile |
Sparingly soluble in water; soluble in dimethyl sulfoxide (DMSO) |
|
Storage Conditions |
Store in tightly closed containers below 25℃, protected from light and moisture |
|
Shelf Life |
36 months from the date of manufacture |
Quality & Specification
|
Test Parameter |
Acceptance Criteria (Ph. Eur. / USP Compliance) |
|
Assay (Dried Basis) |
98.0% - 102.0% |
|
Appearance of Solution |
Clear and yellow solution (in water) |
|
Specific Optical Rotation |
-250° to -265° (c = 0.5 in water) |
|
Water Content (Karl Fischer) |
≤ 1.0% |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals |
≤ 20 ppm |
|
Individual Specified Impurities |
≤ 0.10% |
|
Total Impurities |
≤ 0.5% |
|
Residual Solvents (GC) |
Complies with ICH Q3C limits (Ethanol, Acetone, Dichloromethane) |
Manufacturing & Supply
|
Operational Metric |
Specification / Standard |
|
Production Scale |
Commercial bulk metric tons per annum |
|
Batch Size Capacity |
300 kg - 600 kg per standard production batch |
|
Synthesis Route |
Multi-step convergent synthesis via fluorinated quinoline intermediates |
|
Cleanroom Classification |
Grade D isolation for crystallization, filtration, and drying; Grade C for final packaging |
|
In-Process Controls |
High-performance liquid chromatography (HPLC) reaction monitoring, laser diffraction particle sizing |
|
Supply Lead Time |
4 to 6 weeks for standard commercial orders |
Documentation
Regulatory Dossiers: Open-part and closed-part Drug Master File (DMF) available for submission.
Compliance Certificates: Written Confirmation (WC) for active substances exported to the European Union, Certificate of Suitability (CEP) application support data.
Analytical Validation: Full Certificate of Analysis (CoA) provided per batch, including chiral purity and residual solvent chromatograms.
Safety Data: Comprehensive Safety Data Sheet (SDS) detailing handling, personal protective equipment requirements, and environmental disposal guidelines.
Chain of Custody: Complete traceability documentation covering raw material sourcing, intermediate synthesis logs, and final packaging records.
Packaging
Primary Packaging: Double-layer low-density polyethylene (LDPE) bags, heat-sealed under a filtered nitrogen atmosphere to prevent photo-oxidation and moisture absorption.
Secondary Packaging: Rigid fiber drums or food-grade stainless steel transport containers.
Net Weight Options: 25 kg per drum standard configuration.
Labeling Compliance: Includes product chemical designation, CAS number, batch number, net weight, gross weight, manufacturing date, retest date, and storage precautions.
Pharmaceutical Application
Formulated into oral solid dosage units for treating acute bacterial exacerbations of chronic bronchitis.
Processed into sterile eye drop suspensions for bacterial conjunctivitis management.
Utilized in sterile liquid preparations for severe nosocomial and community-acquired infections.
Applied as an initial IV option transitioning to oral delivery for hospitalized patient pathways.
FAQ
Q: What is the standard batch quantity available for commercial orders?
A: Standard commercial packaging is configured at 25 kg net weight per fiber drum, with cumulative order capacities scaling to metric ton requirements per schedule.
Q: Is an open-part and closed-part DMF accessible for regulatory filing?
A: Yes, a comprehensive Drug Master File structured according to ICH Common Technical Document (CTD) formats is maintained and available for reference upon execution of appropriate confidentiality agreements.
Q: What pharmacopoeial standards does this API comply with?
A: The manufacturing and analytical release testing strictly adhere to current European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) monographs.
Q: How is moisture and light sensitivity managed during transit?
A: Primary packaging utilizes double-layer heat-sealed LDPE bags flushed with nitrogen inside sealed fiber drums to block moisture ingress and UV degradation.
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