Sulopenem is a synthetic penem-class β-lactam antibacterial API developed for activity against a broad range of bacterial pathogens. It contains the characteristic β-lactam pharmacophore associated with penem antibiotics and is classified by the FDA substance registry as a Beta-Lactam Antibiotic.
Sulopenem is the active antibacterial moiety associated with Sulopenem Etzadroxil, an oral prodrug designed to deliver Sulopenem systemically. The two substances are chemically distinct and should be treated as separate APIs in pharmaceutical documentation and CMS records.
Sulopenem has been investigated and developed for the treatment of bacterial infections, including infections caused by susceptible Gram-positive and Gram-negative organisms.
Sulopenem is a stereochemically defined penem antibacterial with five defined stereocenters. FDA GSRS identifies its molecular formula as C₁₂H₁₅NO₅S₃ and molecular weight as 349.45 g/mol.
| Property | Details |
|---|---|
| API Name | Sulopenem |
| CAS Number | 120788-07-0 |
| Molecular Formula | C₁₂H₁₅NO₅S₃ |
| Molecular Weight | 349.45 g/mol |
| Chemical Class | Penem |
| Therapeutic Class | Antibacterial |
| Pharmacological Class | β-Lactam Antibiotic |
| UNII | XX514BJ1XW |
| PubChem CID | 9950244 |
| Synonyms | CP-70429, CP-70,429 |
| Stereochemistry | Absolute stereochemistry |
| Defined Stereocenters | 5 / 5 |
| Physical Form | Solid / powder |
| Active Moiety | Sulopenem |
The FDA and PubChem records independently confirm the chemical identity, CAS number and molecular formula.
Sulopenem is a β-lactam antibacterial API with activity against susceptible bacterial organisms. Its development has focused particularly on bacterial infections where resistance to commonly used antibacterial agents can present a treatment challenge.
Sulopenem is also the active moiety generated from Sulopenem Etzadroxil. FDA substance records establish Sulopenem Etzadroxil as a separate chemical substance whose active form is Sulopenem.
Potential pharmaceutical development applications include:
Sulopenem belongs to the β-lactam antibiotic class. Its antibacterial activity is associated with inhibition of bacterial cell-wall synthesis.
The β-lactam structure enables interaction with bacterial penicillin-binding proteins (PBPs) involved in peptidoglycan synthesis. Inhibition of these enzymes interferes with bacterial cell-wall formation and can ultimately result in bacterial cell death.
Sulopenem is classified in the FDA/NCI substance records as a beta-lactam antibiotic and penem antibacterial.
Sulopenem is a specialized antibacterial API. Unlike APIs with established current USP/BP/Ph. Eur. monographs containing universal numerical limits, a universal public pharmacopoeial release specification for every Sulopenem CMS parameter could not be verified from the authoritative sources reviewed.
Therefore, assay, impurities, water, residue and other release limits should be controlled according to the applicable validated specification rather than assigning unsupported numerical values.
For commercial API release, the final specification should be based on validated analytical methods and the applicable regulatory/customer requirements.
Swapnroop provides API manufacturing and pharmaceutical raw-material solutions for specialized compounds including antibacterial APIs such as Sulopenem, subject to applicable manufacturing and regulatory requirements.
Sulopenem requires controlled manufacturing processes and appropriate analytical controls because β-lactam compounds require careful handling and contamination-control measures.
Sulopenem should be packed in suitable pharmaceutical-grade packaging that protects the material from environmental exposure and maintains its quality during storage and transportation.
Storage requirements for a commercial API should be established from validated stability data rather than adopting conditions from research-reference products.
Depending on the customer's regulatory and quality requirements, documentation may include:
Swapnroop focuses on quality-oriented API manufacturing and pharmaceutical raw-material solutions for specialized compounds.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |