Description

Flucloxacillin Sodium is a semi-synthetic, β-lactamase-resistant penicillin antibiotic. It is a critical active pharmaceutical ingredient (API) valued for its efficacy against penicillinase-producing staphylococci. This compound is essential for pharmaceutical manufacturers developing injectable and oral formulations to treat serious bacterial infections. Its stability and potency make it a key component in anti-infective therapies.

Application

• Pharmaceutical API: Primary use as the active ingredient in sterile injectable solutions (vials, IV bags) and oral capsules/tablets.
• Anti-Staphylococcal Formulations: Specifically targeted for infections caused by penicillin-resistant Staphylococcus aureus.
• Hospital & Clinical Use: Formulated for the treatment of severe infections like osteomyelitis, endocarditis, and deep-seated abscesses.
• Veterinary Medicine: Used in antibiotic preparations for treating bacterial infections in animals.
• Research & Development: Serves as a reference standard and starting material in microbiological and pharmacological research.
• Generic Drug Manufacturing: A key component for companies producing generic antibiotic medications.

Basic Information

Item	Detail
Product Name	Flucloxacillin Sodium
CAS No.	1847-24-1
Molecular Formula	C19H16ClFN3NaO5S
Molecular Weight	493.85 g/mol
Synonyms	Flucloxacillin Sodium Salt; Flucloxacillin Sodium Monohydrate; Floxacillin Sodium; Flucloxacillin Na; (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 sodium salt; Floxapen; Culpen; Stafoxil; EINECS 217-428-3
EINECS	217-428-3

Quality Control

Our Flucloxacillin Sodium is manufactured under strict quality systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and BP. Every batch undergoes comprehensive analytical testing including identification, purity assay, and impurity profiling. A Certificate of Analysis (COA) documenting all test results is provided with each shipment to ensure full traceability and regulatory compliance for our global pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment. For long-term stability, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
pH (10% solution)	5.0 - 7.0
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Bacterial Endotoxins	< 0.25 IU/mg
Sterility (for sterile grade)	Sterile

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