Nemonoxacin is a synthetic non-fluorinated quinolone antibacterial active pharmaceutical ingredient (API). It is structurally related to the quinolone class of antibacterial compounds but differs from many modern fluoroquinolones because it does not contain fluorine in its molecular structure.
Nemonoxacin has been developed as a broad-spectrum antibacterial agent with activity against a range of Gram-positive, Gram-negative and atypical bacterial pathogens. It is also known by the development code TG-873870. FDA's Global Substance Registration System identifies Nemonoxacin as a validated chemical substance with absolute stereochemistry.
Nemonoxacin is a specialized quinolone antibacterial pharmaceutical API relevant to antibacterial drug development, pharmaceutical formulation research, microbiological studies and analytical development.
The molecule is particularly notable for its activity against certain Gram-positive organisms, including Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA), as well as activity against selected Gram-negative and atypical pathogens.
Important API quality attributes include:
Product Name: Nemonoxacin
Development Code: TG-873870
CAS Number: 378746-64-6
Molecular Formula: C20H25N3O4
Molecular Weight: 371.43 g/mol
IUPAC Name: 7-[(3S,5S)-3-amino-5-methylpiperidin-1-yl]-1-cyclopropyl-8-methoxy-4-oxoquinoline-3-carboxylic acid
Drug Class: Non-Fluorinated Quinolone Antibacterial
Therapeutic Class: Antibacterial
Therapeutic Area: Infectious Diseases
Molecule Type: Synthetic Small Molecule
These identity characteristics are supported by the FDA GSRS and PubChem records.
Nemonoxacin acts primarily by interfering with bacterial DNA replication through inhibition of bacterial DNA gyrase and topoisomerase IV.
Its antibacterial activity involves:
NCATS describes nemonoxacin as inhibiting bacterial DNA synthesis through interaction with DNA gyrase and topoisomerase IV.
Nemonoxacin is notable because it is a non-fluorinated quinolone. Unlike fluoroquinolones such as ciprofloxacin and levofloxacin, its chemical structure does not contain the characteristic fluorine substituent.
The molecule contains a substituted quinolone core with a 3-amino-5-methylpiperidinyl group, which contributes to its antibacterial properties. FDA's substance record confirms the defined stereochemistry of the molecule, including two defined stereocenters.
Nemonoxacin has demonstrated antibacterial activity against a variety of pathogens.
Research and technical sources describe activity against:
FDA's substance record includes relationships to several target organisms, including Staphylococcus aureus, MRSA, Streptococcus pneumoniae and Enterococcus faecalis.
Nemonoxacin API is relevant to:
Nemonoxacin has been investigated in oral and intravenous formulations. The active pharmaceutical ingredient may also be encountered in its malate salt/hemihydrate form, depending on the pharmaceutical product and development context.
The malate hemihydrate should not be confused with the parent Nemonoxacin substance. FDA/NCATS identifies Nemonoxacin Malate Hemihydrate as a separate salt/solvate record with CAS 951313-26-1.
Nemonoxacin is a synthetic crystalline small molecule. Commercial and research references describe the material as a solid. A research-grade technical listing reports Nemonoxacin as a solid with a stated purity of 98%, although research-grade material should not automatically be treated as a pharmaceutical release specification.
Physical properties such as particle size, crystallinity and solid-state characteristics should be controlled according to the applicable API specification.
Stereochemistry is an important characteristic of Nemonoxacin.
The FDA GSRS record identifies absolute stereochemistry and two defined stereocenters. The specified active substance corresponds to the (3S,5S) configuration.
Consequently, stereochemical purity should be considered an important quality attribute during manufacturing and analytical characterization.
A controlled Nemonoxacin API manufacturing process may involve:
A publicly available Indian environmental filing provides a representative preparation process involving a quinolone starting material, a (3S,5S)-5-methylpiperidine-derived intermediate, acetonitrile, triethylamine, sodium hydroxide and hydrochloric acid, followed by filtration and drying to produce Nemonoxacin.
The exact commercial process should be based on the manufacturer's validated process and regulatory documentation.
Typical Nemonoxacin API testing may include:
Assay determines the amount of Nemonoxacin present in the API using a validated analytical procedure.
Because Nemonoxacin has defined stereochemistry, stereochemical purity is an important additional quality consideration. Related-substance testing should control process-related impurities, degradation products and unwanted stereoisomeric forms where applicable.
I would not publish an invented universal 98–102% pharmaceutical assay specification for Nemonoxacin unless it is supported by the applicable approved specification or pharmacopoeial standard. A research supplier reporting 98% purity is not sufficient evidence for a commercial API release specification.
Nemonoxacin can also be supplied as Nemonoxacin Malate Hemihydrate, a separate salt/solvate form.
Its reported:
CAS Number: 951313-26-1
Molecular Formula: C48H64N6O19
Molecular Weight: approximately 1029.05 g/mol
FDA/NCATS identifies this material as a salt/solvate related to Nemonoxacin, with Nemonoxacin listed as its active moiety.
For an Nemonoxacin API page, however, the parent API data should remain separate from the malate hemihydrate data.
Store Nemonoxacin API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
A research-grade Nemonoxacin listing recommends 2–8°C and protection from light/inert atmosphere, but this should not automatically be adopted as the commercial API storage specification.
Final storage conditions should be based on validated stability data and the applicable manufacturer's specification.
Nemonoxacin is relevant to research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |