Description

Flucloxacillinmagnesium CAS NO 58486-36-5 is a magnesium salt of the semisynthetic penicillin antibiotic flucloxacillin, offering enhanced stability and formulation properties. This compound is critical for the development of stable, effective antibiotic preparations, particularly in sterile injectable and oral dosage forms. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the production of β-lactamase-resistant penicillin antibiotics.

Application

• Pharmaceutical Active Ingredient (API): Core component in the manufacture of antibiotic formulations targeting penicillinase-producing staphylococci.
• Injectable Antibiotic Preparations: Used in the production of sterile powders for injection or ready-to-use injectable solutions.
• Oral Solid Dosage Forms: Key ingredient in capsules and tablets for oral antibiotic therapy.
• Veterinary Pharmaceutical Products: Formulated for treating bacterial infections in animals.
• Research & Development: Serves as a reference standard and starting material in pharmaceutical R&D for novel antibiotic delivery systems.
• Hospital Compounding: Used in specialized pharmacy compounding for tailored patient treatments.

Basic Information

Product Name	Flucloxacillinmagnesium
CAS No.	58486-36-5
Molecular Formula	C19H16ClFN3O5S • 1/2Mg
Molecular Weight	469.27 g/mol (for C19H16ClFN3O5S • 1/2Mg)
Synonyms	Flucloxacillin Magnesium; Flucloxacillin Mg; Magnesium Flucloxacillin; (2S,5R,6R)-6-[[3-(2-Chloro-6-fluorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]aminoamino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate Magnesium Salt; Floxapen Magnesium; Flucloxacillin Magnesium Salt; Flucloxacillin Magnesium Trihydrate (common form)
EINECS	Contact for details

Quality Control

Our Flucloxacillinmagnesium is manufactured under strict quality systems. It is typically tested to meet specifications aligned with major pharmacopoeial standards such as USP, EP, or BP, ensuring identity, purity, and potency. Certificates of Analysis (COA) documenting critical parameters including assay, related substances, residual solvents, and microbiological quality are provided with each batch to guarantee compliance and traceability.

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 dry environment to prevent degradation. For long-term storage, consider conditions with low humidity.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 8.0% (typically as trihydrate)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with EP/USP
pH (in solution)	5.0 - 7.5

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