Description

Cloxacillin is a semi-synthetic penicillinase-resistant β-lactam antibiotic belonging to the isoxazolyl penicillin class. Its primary value lies in its resistance to degradation by bacterial penicillinase enzymes, making it a critical agent against staphylococcal infections. This product is essential for manufacturers in the pharmaceutical industry, particularly for the formulation of sterile injectables and oral dosage forms. It is also utilized in veterinary medicine and as a reference standard in analytical and research laboratories.

Application

• Pharmaceutical Active Ingredient (API): Core component in the manufacture of antibiotic formulations for human use, targeting penicillinase-producing staphylococci.
• Sterile Injectable Formulations: Used in the production of vials and IV solutions for hospital and clinical treatment of severe bacterial infections.
• Oral Solid Dosage Forms: Key ingredient in capsules and tablets for outpatient antibiotic therapy.
• Veterinary Pharmaceuticals: Incorporated into medications for treating bacterial infections in livestock and companion animals.
• Research & Development: Serves as a biochemical tool and reference standard in microbiological and pharmacological studies.
• Quality Control & Analytical Testing: Used as a certified reference material (CRM) for assay validation, impurity profiling, and HPLC calibration in QC laboratories.

Basic Information

Product Name	Cloxacillin
CAS No.	61-72-3
Molecular Formula	C19H18ClN3O5S
Molecular Weight	435.88 g/mol
Synonyms	(2S,5R,6R)-6-[[[3-(2-Chlorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Cloxacillin Sodium; Cloxacillinum; Orbenin; Tegopen; Cloxapen; 5-Methyl-3-(2-chlorophenyl)-4-isoxazolylpenicillin; BRL-1621
EINECS	200-513-9

Quality Control

Our Cloxacillin is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards such as USP, EP, and BP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and microbiological quality. We support regulatory submissions with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
pH (suspension)	4.5 - 7.5
Microbiological Purity	Meets EP/USP requirements for microbial enumeration

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.