Description

Cloxacillin Sodium is a semi-synthetic penicillinase-resistant penicillin antibiotic. It is a critical active pharmaceutical ingredient (API) valued for its stability against β-lactamase enzymes, making it effective against resistant bacterial strains. This compound is essential for manufacturers in the pharmaceutical industry, particularly for formulating injectable and oral dosage forms to treat staphylococcal infections.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of sterile injectable solutions and oral capsules.
• Veterinary Medicine: Formulation of antibacterial treatments for livestock and companion animals.
• Research & Development: Used as a reference standard and in microbiological studies for antibiotic resistance.
• Bulk Drug Substance: Sourced by contract manufacturing organizations (CMOs) for finished dosage production.

Basic Information

Product Name	Cloxacillin Sodium
CAS No.	7060-81-3
Molecular Formula	C19H17ClN3NaO5S
Molecular Weight	457.86 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 sodium salt; Sodium Cloxacillin; Cloxacillin Sodium Salt; Orbenin; Tegopen; Austrastaph; Cloxapen; Methocillin-S
EINECS	230-325-1

Quality Control

Our Cloxacillin Sodium is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 to prevent degradation.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (Anhydrous basis)	95.0% - 102.0%
pH (10% solution)	5.0 - 7.0
Water (Karl Fischer)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents	Complies with ICH guidelines
Bacterial Endotoxins	< 0.25 IU/mg (if for injectable use)
Sterility (if applicable)	Sterile

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