Sarafloxacin is a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient primarily identified in pharmaceutical and veterinary applications as Sarafloxacin Hydrochloride. The hydrochloride salt is identified by CAS Number 91296-87-6, with the molecular formula C20H17F2N3O3·HCl and molecular weight approximately 421.83 g/mol. FDA substance records recognize Sarafloxacin Hydrochloride as a defined chemical substance, while chemical and analytical reference sources identify it as a fluoroquinolone antibacterial compound.
Sarafloxacin belongs to the fluoroquinolone class of antibacterial agents. Like other compounds in this class, its antibacterial activity is associated with inhibition of bacterial DNA-processing enzymes, particularly DNA gyrase and topoisomerase IV. Interference with these enzymes disrupts bacterial DNA replication and contributes to antibacterial activity.
The pharmaceutical material is commonly handled as Sarafloxacin Hydrochloride rather than the free-base form. The hydrochloride is a 1:1 salt consisting of Sarafloxacin and hydrochloric acid. The corresponding free-base substance is separately identified by CAS Number 98105-99-8.
Sarafloxacin Hydrochloride has the complete molecular representation C20H18ClF2N3O3 and a molecular weight of 421.83 g/mol. FDA GSRS identifies the substance as Sarafloxacin Hydrochloride and assigns UNII I36JP4Q9DF. The compound contains a fluorinated quinolone nucleus with a piperazinyl substituent and fluorophenyl group, characteristic of its fluoroquinolone chemical class.
Commercial reference material is generally described as a white to light-yellow or pale-yellow crystalline powder. TCI reports a minimum HPLC purity of 97.0% and a minimum neutralization-titration purity of 95.0%, while Cayman Chemical reports ≥98% purity for its analytical reference material. These are commercial/reference specifications rather than universal pharmacopoeial API limits.
Sarafloxacin has primarily been associated with veterinary antibacterial applications, including treatment and control of susceptible bacterial infections in poultry and other animal-health settings. Sarafloxacin hydrochloride has been used in veterinary pharmaceutical preparations, including drinking-water formulations.
Because sarafloxacin belongs to the fluoroquinolone class, responsible pharmaceutical and veterinary use requires appropriate control of dosage, susceptibility, resistance considerations and applicable regulatory requirements. Its manufacturing application therefore requires a controlled API quality profile and appropriate analytical documentation.
Quality evaluation of Sarafloxacin Hydrochloride can include identification by infrared spectroscopy, chromatographic assay, related-substance testing, moisture determination, inorganic residue testing and appropriate physical characterization.
Current publicly available sources do not establish a universal USP/BP/Ph. Eur. numerical API release specification for Sarafloxacin Hydrochloride. Consequently, commercial purity values should not be represented as pharmacopoeial requirements.
TCI reports HPLC purity of not less than 97.0 area% and neutralization-titration purity of not less than 95.0%. FUJIFILM Wako reports a minimum HPLC assay of 95.0% for its Sarafloxacin Hydrochloride analytical standard. Other reference suppliers report ≥98% purity. These differences demonstrate why the specification applied to commercial pharmaceutical API should be based on the actual validated product specification rather than a generic research-grade value.
Manufacturing Sarafloxacin Hydrochloride requires control of chemical purity, salt formation, related substances, moisture and residual process materials. HPLC is particularly useful for monitoring the active compound and chromatographic impurities, while spectroscopic identification can confirm chemical identity.
For pharmaceutical manufacturing, batch-specific documentation can include Certificates of Analysis, analytical test reports, HPLC chromatograms, product specifications, Safety Data Sheets, residual-solvent information and other technical documentation appropriate to the intended application.
Sarafloxacin Hydrochloride should be protected from excessive heat, moisture and contamination. Reference suppliers use refrigerated or low-temperature storage for analytical material; TCI specifies storage at 0–10°C, while other analytical sources recommend approximately −20°C.
These research/reference storage conditions should not automatically be presented as a universal commercial API storage requirement. Commercial storage should follow validated stability data, packaging studies and the manufacturer's approved specification.
Typical Sarafloxacin API documentation may include a Certificate of Analysis, product specification, batch analytical report, HPLC chromatogram, residual-solvent information, Safety Data Sheet, Certificate of Origin where applicable, stability information and technical documentation.
Sarafloxacin Hydrochloride is a defined fluoroquinolone antibacterial substance with established chemical identity and commercially available analytical reference standards. Consistent control of identity, chromatographic purity, salt form, moisture and related substances is important for reliable pharmaceutical and veterinary manufacturing.
For commercial API applications, quality specifications should be established using validated analytical methods and the applicable regulatory requirements for the intended market and dosage form.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |