Moxifloxacin Hydrochloride API Manufacturer in India

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Moxifloxacin Hydrochloride API

Moxifloxacin Hydrochloride is the hydrochloride salt of moxifloxacin, a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient (API). It is used in pharmaceutical formulation development and manufacturing for antibacterial products. Moxifloxacin exerts its antibacterial activity primarily through inhibition of bacterial DNA gyrase and topoisomerase IV.

Moxifloxacin Hydrochloride has CAS Number 186826-86-8, molecular formula C21H24FN3O4·HCl, and molecular weight 437.89 g/mol.

Moxifloxacin Hydrochloride API Manufacturer in India

Moxifloxacin Hydrochloride is an established pharmaceutical API used in the development of oral and ophthalmic antibacterial formulations. The API is characterized through analytical parameters including identity, assay, related substances, water content, residual solvents and other applicable quality attributes.

Chemical Information

CAS Number: 186826-86-8

Alternate CAS / CAS 2: 192927-63-2 (Moxifloxacin Hydrochloride Monohydrate)

Molecular Formula: C21H24FN3O4·HCl

Molecular Weight: 437.89 g/mol

Chemical Name: 1-Cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride

Drug Class: Fluoroquinolone Antibacterial

Therapeutic Class: Antibacterial

Therapeutic Area: Infectious Diseases / Ophthalmology

Molecule Type: Synthetic Small Molecule

Mechanism of Action

Moxifloxacin Hydrochloride acts through inhibition of bacterial DNA gyrase and topoisomerase IV.

Its antibacterial activity involves:

  • Inhibition of DNA gyrase
  • Inhibition of topoisomerase IV
  • Interference with bacterial DNA replication
  • Disruption of DNA repair and transcription
  • Inhibition of bacterial cell growth
  • Bactericidal activity against susceptible bacteria

Pharmaceutical Applications

Moxifloxacin Hydrochloride API is used in the development of:

  • Antibacterial pharmaceutical formulations
  • Fluoroquinolone antibiotic products
  • Oral antibacterial formulations
  • Ophthalmic formulations
  • Infectious disease drug development
  • Pharmaceutical research and development
  • Analytical and quality-control research

Antibacterial Applications

Moxifloxacin is a broad-spectrum fluoroquinolone antibacterial compound with activity against a variety of susceptible Gram-positive and Gram-negative bacteria and selected atypical microorganisms.

Its hydrochloride salt form is used as the active pharmaceutical ingredient in various pharmaceutical development programs.

Physical Characteristics

Moxifloxacin Hydrochloride is generally characterized as a crystalline solid. The precise particle size, polymorphic characteristics, water content and other physical attributes should be controlled according to the applicable API specification.

The monohydrate form contains water of crystallization and has a different molecular weight from anhydrous Moxifloxacin Hydrochloride.

Manufacturing Process

A controlled Moxifloxacin Hydrochloride API manufacturing process may include:

  1. Qualified starting-material preparation
  2. Synthesis of quinolone intermediates
  3. Introduction of the required substituents
  4. Formation of the characteristic bicyclic amine structure
  5. Reaction completion and purification
  6. Hydrochloride salt formation
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Milling, where required
  11. Final analytical testing
  12. GMP-compliant packaging

Quality Control Testing

Typical quality-control testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Specific optical rotation
  • Solid-state or polymorphic characterization
  • Particle-size testing, where applicable
  • Stability testing

Storage

Moxifloxacin Hydrochloride API should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should be based on validated stability data and the applicable approved API specification.

Pharmaceutical Research

Moxifloxacin Hydrochloride is relevant to research involving:

  • Fluoroquinolone antibacterial agents
  • DNA gyrase inhibition
  • Topoisomerase IV inhibition
  • Antimicrobial drug development
  • Bacterial DNA replication
  • Infectious disease research
  • Ophthalmic drug development
  • Pharmaceutical formulation development
  • Analytical method development

Moxifloxacin Hydrochloride API Summary

Moxifloxacin Hydrochloride is a fluoroquinolone antibacterial API with CAS Number 186826-86-8, molecular formula C21H24FN3O4·HCl, and molecular weight 437.89 g/mol. It inhibits bacterial DNA gyrase and topoisomerase IV and is used in pharmaceutical development for antibacterial formulations.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point Approximately 324°C, with decomposition
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