Cloxacillin is a semi-synthetic penicillin-class antibacterial active pharmaceutical ingredient (API). It belongs to the isoxazolyl penicillin group and is used in pharmaceutical formulations for the treatment of infections caused by susceptible Gram-positive bacteria, including penicillinase-producing strains of Staphylococcus aureus.
Cloxacillin is chemically related to other isoxazolyl penicillins and is designed to resist degradation by bacterial penicillinase enzymes. It is supplied as a pharmaceutical API for formulation and manufacturing applications.
Cloxacillin API is supplied for pharmaceutical formulation and manufacturing applications. The material is subject to appropriate quality control testing to verify identity, assay, purity and other relevant pharmaceutical quality characteristics.
Cloxacillin is used as an antibacterial pharmaceutical ingredient. Its activity is associated particularly with susceptible Gram-positive organisms, including penicillinase-producing Staphylococcus species.
Cloxacillin API is evaluated using appropriate pharmaceutical analytical procedures. Testing can include identification, assay, related substances, water content, optical rotation, residual solvents and other applicable quality parameters.
Quality documentation such as Certificate of Analysis (CoA), specification sheets and Safety Data Sheets (SDS) can be provided according to applicable requirements.
Store Cloxacillin API in a tightly closed container under controlled conditions specified by the applicable product specification and SDS. Protect from excessive moisture, heat and direct light. Handle according to appropriate pharmaceutical material-handling procedures.
Cloxacillin API can be supplied to pharmaceutical manufacturers, formulation companies, distributors and qualified industry customers. Packaging, documentation and commercial supply conditions can be discussed according to customer requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | ≤ 0.5% |
| Melting Point | 115°C |