Moxifloxacin HCl API Manufacturer in India

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Moxifloxacin HCl API

Moxifloxacin Hydrochloride (Moxifloxacin HCl) is a synthetic fluoroquinolone antibacterial API used in the development and manufacture of pharmaceutical formulations. It is the hydrochloride salt of moxifloxacin and acts primarily by inhibiting bacterial DNA gyrase and topoisomerase IV.

Moxifloxacin Hydrochloride is identified by CAS Number 186826-86-8, with the molecular formula C21H24FN3O4·HCl and molecular weight of approximately 437.89 g/mol. USP defines Moxifloxacin Hydrochloride as containing 98.0% to 102.0% of moxifloxacin hydrochloride, calculated on the anhydrous basis.

Moxifloxacin HCl API Manufacturer in India

Moxifloxacin HCl is an established antibacterial pharmaceutical API used for formulation development, pharmaceutical manufacturing and analytical research. Its quality evaluation includes chemical identification, assay, related substances, water content and other applicable quality attributes.

Moxifloxacin Hydrochloride is also available as a monohydrate form, which has a different molecular formula and molecular weight. The monohydrate is identified by CAS Number 192927-63-2 and molecular weight approximately 455.9 g/mol.

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-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid monohydrochloride

Drug Class: Fluoroquinolone Antibacterial

Therapeutic Class: Antibacterial

Therapeutic Area: Infectious Diseases

Molecule Type: Synthetic Small Molecule

Mechanism of Action

Moxifloxacin inhibits the bacterial enzymes DNA gyrase (topoisomerase II) and topoisomerase IV.

Its antibacterial activity includes:

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

By interfering with essential bacterial DNA processes, Moxifloxacin inhibits bacterial growth and contributes to bacterial cell death.

Pharmaceutical Applications

Moxifloxacin HCl API is used in pharmaceutical development for:

  • Antibacterial formulations
  • Fluoroquinolone antibiotic development
  • Infectious disease pharmaceutical research
  • Oral pharmaceutical formulation development
  • Ophthalmic formulation development
  • Pharmaceutical research and development
  • Analytical and quality-control testing

Antibacterial Applications

Moxifloxacin is a broad-spectrum fluoroquinolone antibacterial compound with activity against susceptible Gram-positive and Gram-negative bacteria, as well as selected atypical and anaerobic organisms.

It is used as an active pharmaceutical ingredient in different pharmaceutical dosage-form development programs, depending on the applicable regulatory requirements and formulation.

Physical Characteristics

Moxifloxacin Hydrochloride is a crystalline pharmaceutical substance. Its exact physical appearance, particle characteristics and solid-state properties should be controlled according to the applicable API specification.

Moxifloxacin Hydrochloride Monohydrate is a distinct solid form containing one molecule of water per moxifloxacin hydrochloride molecule and should not be confused with the anhydrous hydrochloride form.

Manufacturing Process

A controlled Moxifloxacin HCl API manufacturing process may involve:

  1. Preparation of qualified starting materials
  2. Synthesis of quinolone intermediates
  3. Introduction of the fluorinated and methoxy substituents
  4. Formation of the pyrrolopyridine-containing structure
  5. Controlled reaction and purification
  6. Formation of the hydrochloride salt
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Milling, where required
  11. Final analytical testing
  12. GMP-compliant packaging

Quality Control Testing

Typical Moxifloxacin HCl API testing may include:

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

Storage

Store Moxifloxacin HCl API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage requirements should follow validated stability data and the approved product specification.

Pharmaceutical Research

Moxifloxacin Hydrochloride is relevant to research involving:

  • Fluoroquinolone antibiotics
  • DNA gyrase inhibition
  • Topoisomerase IV inhibition
  • Bacterial DNA replication
  • Antibacterial drug development
  • Infectious disease research
  • Antimicrobial pharmacology
  • Pharmaceutical formulation development
  • Analytical method development

Moxifloxacin HCl API Summary

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

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 (decomposition)
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