Gatifloxacin API Manufacturer in India

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Gatifloxacin API Manufacturer and Bulk Supplier in India

Gatifloxacin API (CAS No: 112811-59-3)

 

Gatifloxacin API (CAS No. 112811-59-3) is a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient associated with ophthalmic, anti-infective, and antibacterial pharmaceutical formulations.

Gatifloxacin is an 8-methoxy fluoroquinolone antibacterial compound. It acts by inhibiting bacterial DNA gyrase and topoisomerase IV, two essential bacterial enzymes involved in DNA replication, transcription, repair, and chromosome separation.

Inhibition of these bacterial topoisomerase enzymes interferes with DNA replication and prevents susceptible bacterial cells from multiplying.

Gatifloxacin is particularly associated with topical ophthalmic pharmaceutical formulations developed for bacterial eye infections caused by susceptible microorganisms.

Pharmaceutical companies sourcing Gatifloxacin API commonly evaluate assay, HPLC purity, related substances, process-related impurities, degradation products, residual solvents, water content, crystalline characteristics, particle size distribution, and batch-to-batch consistency.

Gatifloxacin may be encountered in anhydrous and hydrated material forms. Therefore, water content, hydrate-form identity, molecular specification, and solid-state characteristics should be carefully evaluated during API procurement and quality qualification.

Particle size distribution and physical API characteristics may also be important for ophthalmic formulation development and pharmaceutical processing requirements.

Swapnroop Drugs and Pharmaceuticals supplies Gatifloxacin API for qualified pharmaceutical research, ophthalmic formulation development, antibacterial drug development, analytical, generic drug development, and regulated manufacturing requirements with product-specific quality documentation, pharmaceutical-grade packaging, and reliable supply-chain coordination.

Critical Quality Requirements for Gatifloxacin API

Pharmaceutical companies evaluating Gatifloxacin API commonly focus on:

  • HPLC assay and chromatographic purity
  • Chemical identity
  • Related substances
  • Process-related impurity control
  • Degradation product monitoring
  • Water content
  • Hydrate-form identity
  • Residual solvent profile
  • Elemental impurity assessment
  • Crystal-form consistency
  • Particle size distribution
  • Powder handling characteristics
  • Batch-to-batch consistency
  • Stability under recommended storage conditions

Hydrate-form and water-content control are important considerations for Gatifloxacin API because the pharmaceutical material may be supplied in specific hydrated forms.

Impurity-profile control is also important during API qualification. Pharmaceutical manufacturers may evaluate process-related impurities, degradation products, related substances, and chromatographic purity according to the approved API specification.

Key Features

  • Gatifloxacin API CAS No. 112811-59-3
  • Synthetic fluoroquinolone antibacterial active ingredient
  • 8-methoxy fluoroquinolone pharmaceutical compound
  • DNA gyrase inhibitor
  • Bacterial topoisomerase IV inhibitor
  • Molecular formula C19H22FN3O4
  • Molecular weight approximately 375.40 g/mol
  • White to pale yellow crystalline powder
  • Controlled HPLC purity profile
  • Related substances monitored according to approved specification
  • Hydrate-form and water-content evaluation
  • Process and degradation impurity monitoring
  • Crystal-form consistency evaluation
  • Particle size requirements coordinated as applicable
  • Residual solvents controlled according to applicable ICH Q3C requirements
  • Elemental impurities evaluated according to applicable ICH Q3D requirements
  • Pharmaceutical-grade packaging
  • COA and MSDS available as applicable
  • Bulk pharmaceutical supply and export coordination

Applications of Gatifloxacin API

Gatifloxacin API is primarily associated with:

  • Ophthalmic antibacterial pharmaceutical development
  • Bacterial conjunctivitis pharmaceutical formulations
  • Antibacterial eye drop development
  • Topical ophthalmic solution development
  • Fluoroquinolone pharmaceutical research
  • DNA gyrase inhibitor research
  • Topoisomerase IV inhibitor research
  • Anti-infective pharmaceutical development
  • Generic ophthalmic drug development
  • Antibacterial analytical research
  • Pharmaceutical formulation development
  • Approved pharmaceutical manufacturing requirements

Gatifloxacin ophthalmic pharmaceutical products are associated with treatment of bacterial conjunctivitis caused by susceptible microorganisms.

Gatifloxacin API for Ophthalmic Pharmaceutical Development

Gatifloxacin is widely associated with topical ophthalmic antibacterial pharmaceutical products.

Pharmaceutical formulation companies evaluating Gatifloxacin API may review:

  • API assay
  • HPLC purity
  • Chemical identification
  • Related substance profile
  • Process-related impurities
  • Degradation products
  • Water content
  • Hydrate form
  • Residual solvents
  • Crystal form
  • Particle size distribution
  • Solution characteristics
  • Formulation compatibility
  • Stability data
  • Batch-to-batch consistency

Product-specific API specifications should be evaluated according to the intended ophthalmic dosage form, formulation process, target regulatory market, and approved pharmaceutical development requirements.

Gatifloxacin Mechanism of Antibacterial Activity

Gatifloxacin inhibits bacterial DNA gyrase and bacterial topoisomerase IV.

DNA gyrase is involved in maintaining bacterial DNA topology during replication.

Topoisomerase IV contributes to separation of replicated bacterial chromosomes.

Inhibition of these essential enzymes interferes with bacterial DNA replication and chromosome processing, resulting in antibacterial activity against susceptible microorganisms.

Gatifloxacin API and Ophthalmic Formulations

Gatifloxacin is associated with sterile ophthalmic solution products for bacterial eye infections.

Formulation-development considerations may include:

  • API identity and purity
  • Hydrate form
  • Water content
  • pH-dependent solubility
  • Solution clarity
  • Solution color
  • Drug-excipient compatibility
  • Sterile manufacturing compatibility
  • Ophthalmic formulation pH
  • Stability under intended packaging conditions

API specifications should be coordinated with the intended sterile ophthalmic formulation and applicable regulatory requirements.

Gatifloxacin and Gatifloxacin Sesquihydrate

Gatifloxacin and Gatifloxacin Sesquihydrate should be evaluated according to the exact pharmaceutical material form.

Gatifloxacin has CAS No. 112811-59-3 and molecular formula C19H22FN3O4.

Gatifloxacin Sesquihydrate is a hydrated material form associated with ophthalmic pharmaceutical products and may be identified separately according to supplier and regulatory documentation.

The sesquihydrate material has a calculated molecular weight of approximately 402.42 g/mol when expressed as C19H22FN3O4·1.5H2O.

Procurement, formulation, quality, and regulatory teams should confirm the exact anhydrous or hydrate form before commercial sourcing.

Why Choose Swapnroop for Gatifloxacin API?

Swapnroop Drugs and Pharmaceuticals supports qualified pharmaceutical and ophthalmic-development customers with:

  • Reliable Gatifloxacin API supply coordination
  • Product-specific specification support
  • COA and MSDS availability as applicable
  • Technical documentation coordination
  • Related substance specification support
  • Hydrate-form requirement coordination
  • Particle size requirement coordination as applicable
  • Secure pharmaceutical-grade packaging
  • Bulk quantity supply support
  • Export documentation assistance
  • Global pharmaceutical supply coordination
  • Dedicated commercial enquiry support
  • Support for ophthalmic and antibacterial pharmaceutical development requirements

Packaging & Supply

Gatifloxacin API is supplied in secure pharmaceutical-grade packaging selected according to product quantity, hydrate form, stability requirements, moisture protection requirements, and customer specifications.

Product-appropriate inner polyethylene liners and approved pharmaceutical-grade outer containers or HDPE drums may be used according to the supplied material specification.

Available packaging configurations may include:

  • 1 kg packaging
  • 5 kg packaging
  • 10 kg packaging
  • 25 kg packaging
  • Customer-specific packaging as applicable

Packaging configuration, MOQ, commercial quantity, hydrate-form requirements, particle size requirements, and shipment conditions are confirmed according to the approved product specification and customer enquiry.

Storage and Handling

Store Gatifloxacin API in tightly closed and appropriately labeled containers under recommended controlled storage conditions.

Protect the material from excessive moisture, heat, direct light, and unsuitable environmental exposure.

Handling should be performed by trained personnel using approved pharmaceutical raw material handling procedures and applicable safety documentation.

Product-specific storage and handling requirements should be confirmed from the approved COA, SDS, specification, and stability documentation.

Gatifloxacin API Manufacturer and Supplier in India

Swapnroop Drugs and Pharmaceuticals provides Gatifloxacin API bulk supply and export support in India for qualified pharmaceutical manufacturers, ophthalmic formulation developers, antibacterial drug companies, generic pharmaceutical companies, analytical laboratories, and pharmaceutical procurement customers.

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