Tosufloxacin API Manufacturer and Supplier in India

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Tosufloxacin API Manufacturer and Supplier in India

Tosufloxacin is a synthetic fluoroquinolone antibacterial API belonging to the quinolone class. It is chemically classified as a 1,8-naphthyridine derivative and is identified by the molecular formula C₁₉H₁₅F₃N₄O₃ with a molecular weight of approximately 404.3 g/mol. PubChem and the FDA Global Substance Registration System identify Tosufloxacin as an established pharmaceutical substance, with CAS 100490-36-6 for the free base.

Tosufloxacin is classified under the WHO ATC system as J01MA22, within the fluoroquinolone antibacterial group.

API Overview

Tosufloxacin is a broad-spectrum antibacterial compound developed as a fluoroquinolone antimicrobial. Its chemical structure incorporates a fluorinated aromatic ring, a 1,8-naphthyridine core, a carboxylic acid group and an aminopyrrolidine substituent. The compound is associated with inhibition of bacterial DNA gyrase and topoisomerase IV, mechanisms characteristic of fluoroquinolone antibacterial activity.

Tosufloxacin is commonly encountered commercially in its tosilate/tosylate form, particularly Tosufloxacin Tosilate Hydrate, while Tosufloxacin itself represents the active moiety/free-base substance. The Japanese Pharmacopoeia identifies Tosufloxacin Tosilate Hydrate as a pharmaceutical substance with the formula-based molecular mass of 594.56 g/mol for the monohydrate form.

Chemical and Pharmaceutical Profile

PropertyDetails
Product NameTosufloxacin
API TypeSynthetic small-molecule API
Therapeutic ClassFluoroquinolone antibacterial
CAS Number100490-36-6
Molecular FormulaC₁₉H₁₅F₃N₄O₃
Molecular Weight404.3 g/mol
UNIIGHJ553KQPS
ATC CodeJ01MA22
AppearanceWhite to off-white/pale yellow powder*
Active MoietyTosufloxacin
Common Pharmaceutical SaltTosufloxacin Tosilate/Tosylate Hydrate
StorageControlled pharmaceutical storage conditions

*Appearance is based on publicly available reference material rather than a universal pharmacopoeial free-base specification.

Pharmaceutical Applications

Tosufloxacin is classified as a fluoroquinolone antibacterial agent and is associated with antibacterial treatment applications. Its WHO ATC classification is J01MA22, and WHO's ATC/DDD index lists an oral defined daily dose of 0.45 g.

Tosufloxacin is also used in pharmaceutical development and manufacturing principally through its tosilate/tosylate salt, including Tosufloxacin Tosilate Hydrate. Japanese pharmaceutical information identifies this form as a new-quinolone oral antibacterial preparation.

Tosufloxacin API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals offers pharmaceutical API sourcing and supply solutions for Tosufloxacin for customers requiring quality-focused active pharmaceutical ingredients. Tosufloxacin can be supplied for pharmaceutical manufacturing, formulation development, research and other qualified applications, subject to applicable specifications and documentation.

As an API manufacturer and supplier in India, Swapnroop Drugs & Pharmaceuticals focuses on controlled sourcing, analytical documentation, appropriate packaging and batch-level quality requirements. Customers can request product specifications, Certificate of Analysis (CoA), technical documentation and other relevant quality documents according to their intended application.

Packaging and Storage

Tosufloxacin should be stored in appropriately sealed pharmaceutical-grade packaging under conditions established by the applicable product specification and stability data. Protection from excessive moisture, heat and unsuitable light exposure should be maintained.

Packaging configurations can be selected according to customer requirements, batch size and intended pharmaceutical application.

Documentation

Typical documentation available upon request may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS/MSDS)
  • Technical Data Sheet
  • Batch-related analytical documentation
  • Manufacturing and quality documentation, where applicable
  • Regulatory documentation, subject to product availability and customer requirements

Why Choose Tosufloxacin API from Swapnroop?

Swapnroop Drugs & Pharmaceuticals provides a professional API sourcing and supply platform for pharmaceutical manufacturers and formulation companies seeking Tosufloxacin API in India and international markets. The company emphasizes product traceability, specification-based quality assessment, suitable packaging and documentation support.

For pharmaceutical companies looking for a Tosufloxacin API manufacturer and supplier in India, Swapnroop can support bulk API requirements according to agreed technical and commercial specifications.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.5%
Loss on Drying 3.0–4.5%
Residue on Ignition NMT 0.2%
Heavy Metals NMT 20 ppm
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