Description

Flucloxacillin is a semisynthetic, β-lactamase-resistant penicillin antibiotic. It is a critical active pharmaceutical ingredient (API) valued for its efficacy against penicillinase-producing staphylococci, including methicillin-sensitive *Staphylococcus aureus* (MSSA). This compound is essential for pharmaceutical manufacturers developing sterile injectable formulations, oral capsules, and other dosage forms. Its primary application is in the treatment of bacterial infections such as skin and soft tissue infections, osteomyelitis, and endocarditis.

Application

• Pharmaceutical API: Core ingredient in the manufacture of generic antibiotic formulations.
• Injectable Solutions: Used in sterile powder for injection to treat severe systemic infections.
• Oral Dosage Forms: Formulated into capsules and tablets for outpatient treatment.
• Combination Therapies: May be used in conjunction with other antibiotics for broad-spectrum coverage.
• Veterinary Medicine: Employed in certain antibiotic preparations for animal health.
• Research & Development: Serves as a reference standard and in pharmacological studies for antibiotic resistance.

Basic Information

Product Name	Flucloxacillin
CAS No.	5250-39-5
Molecular Formula	C19H17ClFN3O5S
Molecular Weight	453.87 g/mol
Synonyms	Flucloxacillin Sodium; Floxacillin; Flucloxacillinum; (2S,5R,6R)-6-[[[3-(2-Chloro-6-fluorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino](3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Floxapen; Culpen; Staphylex; Flucloxacillin Monohydrate; Flucloxacillin Anhydrous
EINECS	226-052-8

Quality Control

Our Flucloxacillin is manufactured under strict quality management systems. It is tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeias such as USP, EP, and BP. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure regulatory compliance and batch-to-batch consistency.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 6.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	+163° to +172° (c=1 in H2O)
pH (1% aqueous solution)	5.0 - 7.0

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