Active Pharmaceutical Ingredient

Sitafloxacin — CAS 127254-12-0

Also known as: Gracevit; DU-6859a

GMP Certified IP / BP / EP / USP Fluoroquinolone Antibiotic Aurangabad, India
Sitafloxacin API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sitafloxacin IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 127254-12-0

Product Overview

Sitafloxacin is a potent fourth-generation fluoroquinolone antibiotic with exceptionally broad-spectrum antibacterial activity, including activity against drug-resistant organisms such as MRSA and PRSP. It inhibits DNA gyrase and topoisomerase IV. Mediocon Inc manufactures GMP-certified Sitafloxacin API at its Aurangabad facility.

Therapeutic Applications
  • Respiratory tract infections
  • Urinary tract infections
  • Broad-spectrum antibiotic therapy
  • Drug-resistant bacterial infections

Technical Specifications

ParameterSpecification
CAS Number127254-12-0
Molecular FormulaC₁₉H₁₈ClF₂N₃O₃
Molecular Weight409.81 g/mol
GradeIP / BP / EP / USP
CategoryFluoroquinolone Antibiotic
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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