Rosoxacin API is a synthetic quinolone antibacterial active pharmaceutical ingredient. It is also known as Acrosoxacin and has been classified as a quinolone antibiotic with antibacterial activity against susceptible Gram-negative and Gram-positive organisms. Rosoxacin is an established but older antibacterial compound and is associated particularly with treatment of certain genitourinary infections.
Rosoxacin is identified by the chemical name 1-ethyl-4-oxo-7-pyridin-4-ylquinoline-3-carboxylic acid. Its molecular formula is C17H14N2O3, with a molecular weight of 294.31 g/mol.
Rosoxacin belongs to the quinolone class of synthetic antibacterial compounds. Its structure contains a quinolone carboxylic-acid core substituted with an ethyl group and a pyridinyl moiety. The molecule is chemically distinct from later-generation fluoroquinolones because it does not contain a fluorine substituent.
FDA's Global Substance Registration System identifies Rosoxacin under UNII 3Y1OT3J4NW, with the formula C17H14N2O3 and the CAS number 40034-42-2.
Rosoxacin has historically been used as an oral antibacterial agent, particularly for susceptible infections involving Neisseria gonorrhoeae and certain urinary or sexually transmitted infections. Available clinical drug information identifies uncomplicated gonorrhoea as an oral indication.
Because Rosoxacin is an older antibacterial agent, its current pharmaceutical availability and approved indications may vary by country and regulatory market.
Rosoxacin acts as a quinolone antibacterial agent by interfering with bacterial DNA replication. Quinolone antibacterial activity is associated with inhibition of bacterial DNA gyrase and related topoisomerase enzymes, disrupting DNA synthesis and ultimately leading to bacterial cell death. AntibioticDB classifies Rosoxacin as a DNA synthesis inhibitor and DNA gyrase inhibitor.
Quality control of Rosoxacin API should include appropriate testing for identity, assay, related substances, residual solvents, water content and other applicable pharmaceutical quality attributes.
Depending on the intended API specification, analytical characterization may include chromatographic purity testing, spectroscopic identification and physicochemical testing. Because no current universal numerical API specification was verified from an authoritative public pharmacopeial source during this research, release limits should be established according to the applicable validated manufacturer specification rather than presented as universal values.
Rosoxacin API is a synthetic small-molecule pharmaceutical compound. Manufacturing involves controlled chemical synthesis, purification and isolation of the active ingredient followed by analytical testing against the approved API specification.
Appropriate manufacturing controls should address starting-material quality, reaction parameters, process-related impurities, purification efficiency, residual solvents and final-product consistency.
Rosoxacin is a defined small-molecule quinolone compound.
Key characteristics include:
Rosoxacin API should be packed in suitable pharmaceutical-grade containers that protect the material from contamination, moisture and inappropriate environmental exposure.
Storage conditions should follow the manufacturer's validated stability data and approved API specification. Containers should remain properly closed during storage and handling.
A qualified Rosoxacin API manufacturer can provide applicable technical and quality documentation, including:
A qualified Rosoxacin API manufacturer in India can support pharmaceutical companies requiring controlled-quality Rosoxacin for applicable pharmaceutical development and manufacturing requirements.
Important quality considerations include chemical identity, assay, impurity control, residual solvents, physical properties and consistent batch-to-batch manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |