Rufloxacin API is a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient used in the development and manufacture of antibacterial medicines. The pharmaceutical form commonly identified for Rufloxacin is Rufloxacin Hydrochloride, a hydrochloride salt of the active moiety Rufloxacin. Rufloxacin belongs to the quinolone/fluoroquinolone class of antibacterial compounds and is associated with inhibition of bacterial DNA gyrase and topoisomerase IV.
Rufloxacin Hydrochloride is identified by CAS 106017-08-7 and has a molecular formula of C₁₇H₁₉ClFN₃O₃S with a molecular weight of approximately 399.87 g/mol.
Rufloxacin is a structurally distinct fluoroquinolone antibacterial containing a fluorinated quinolone-type nucleus and sulfur-containing ring system. The hydrochloride salt provides the pharmaceutical form associated with Rufloxacin drug substances.
Rufloxacin has historically been investigated and used as an orally active antibacterial agent, particularly in urinary and respiratory bacterial infections. It has activity against selected Gram-negative and Gram-positive organisms and acts primarily by interfering with bacterial enzymes required for DNA replication.
| Property | Details |
|---|---|
| Product | Rufloxacin |
| Pharmaceutical form | Rufloxacin Hydrochloride |
| CAS Number | 106017-08-7 |
| Parent Rufloxacin CAS | 101363-10-4 |
| Molecular Formula | C₁₇H₁₉ClFN₃O₃S |
| Molecular Weight | 399.87 g/mol |
| Drug Class | Fluoroquinolone antibacterial |
| ATC | J01MA10 |
| Physical form | Crystalline solid |
| Appearance | Off-white to light-green / pale-yellow crystalline solid |
| Active moiety | Rufloxacin |
| Pharmaceutical salt | Hydrochloride |
The identity and molecular data are supported by PubChem, FDA GSRS-linked substance records and EPA CompTox.
Rufloxacin Hydrochloride has been associated with antibacterial treatment, particularly infections involving susceptible bacterial organisms. Historical pharmaceutical use includes urinary tract infections, respiratory tract infections and chronic bacterial prostatitis.
As a fluoroquinolone, Rufloxacin acts on bacterial DNA-processing enzymes, principally DNA gyrase and topoisomerase IV, thereby interfering with bacterial DNA replication and cellular survival.
For API manufacturing and pharmaceutical development, the material can be evaluated for identity, purity, inorganic residues, moisture and other quality attributes using validated analytical procedures.
Rufloxacin Hydrochloride should be evaluated using appropriate validated analytical methods. Typical quality evaluation includes infrared identification, chromatographic purity/assay, loss on drying, residue on ignition, heavy metals and physical-property testing.
A current publicly accessible pharmacopoeial numerical specification could not be verified for all of these parameters. Therefore, numerical values should not be represented as universal USP/BP/Ph. Eur. requirements.
A commercial analytical COA for Rufloxacin Hydrochloride reports the following reference specifications: purity ≥98%, loss on drying ≤2.0%, residue on ignition ≤0.2%, heavy metals ≤20 ppm and sulfated ash ≤0.2%.
Rufloxacin Hydrochloride API can be manufactured and evaluated under controlled pharmaceutical quality systems with analytical testing appropriate for the drug substance. Manufacturing controls can include raw-material qualification, process controls, validated analytical methods, impurity monitoring and batch-wise quality assessment.
Technical documentation can include certificates of analysis, analytical test reports, specification sheets, safety documentation and other quality documents applicable to the API.
Rufloxacin Hydrochloride is supplied as a crystalline solid. Commercial analytical sources recommend storage at approximately −20°C for research/reference material.
For commercial API storage, the final storage condition should follow the validated stability program and approved product-specific packaging specification rather than automatically adopting research-reagent storage conditions.
Suitable pharmaceutical packaging should protect the material from moisture, contamination and inappropriate environmental exposure.
Typical API documentation may include:
Rufloxacin Hydrochloride is a well-characterized synthetic fluoroquinolone antibacterial API with established chemical identity and analytical reference information. Its defined molecular structure, hydrochloride salt form and established analytical methods make appropriate characterization important for pharmaceutical development and quality control.
For commercial API evaluation, specifications should always be agreed according to the intended application, applicable pharmacopoeial requirements and the manufacturer's validated quality system.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.20% |
| Heavy Metals | NMT 20 ppm |
| Melting Point | 322–324°C |