Description

Cloxacillin Sodium Sterile is a semi-synthetic, β-lactamase-resistant penicillin antibiotic in its sodium salt form. This compound is critical for formulating sterile injectable pharmaceuticals, offering targeted efficacy against penicillinase-producing staphylococci. It is primarily required by pharmaceutical manufacturers and compounding facilities for the production of parenteral antibiotics to treat serious bacterial infections.

Application

• Primary active pharmaceutical ingredient (API) in sterile injectable formulations.
• Manufacturing of lyophilized (freeze-dried) powder for injection.
• Use in hospital compounding for specialized antibiotic preparations.
• Research and development of novel antibiotic delivery systems.
• Reference standard in pharmaceutical quality control laboratories.
• Production of combination antibiotic therapies for broad-spectrum coverage.

Basic Information

Product Name	Cloxacillin Sodium Sterile
CAS No.	70814-41-4
Molecular Formula	C19H17ClN3NaO5S
Molecular Weight	457.86 g/mol
Synonyms	(2S,5R,6R)-6-[[[3-(2-Chlorophenyl)-5-methyl-4-isoxazolyl]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; BRL-1621; Orbenin; Tegopen; Methocillin-S; Ankerbin; Cloxapen
EINECS	Contact for details

Quality Control

Our Cloxacillin Sodium Sterile is manufactured under strict cGMP conditions, ensuring compliance with major pharmacopoeial standards such as USP, EP, and BP. Each batch undergoes comprehensive analytical testing including sterility, bacterial endotoxins (LAL), and particulate matter analysis. A detailed Certificate of Analysis (COA) and supporting documentation for regulatory filings (e.g., DMF) are provided to guarantee traceability and quality assurance for pharmaceutical production.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in its original sealed container under low-humidity conditions to maintain stability and sterility.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	95.0% - 102.0% (on anhydrous basis)
pH (10% solution)	5.0 - 7.0
Water Content (KF)	≤ 5.0%
Specific Optical Rotation	+163° to +172°
Heavy Metals	≤ 20 ppm
Sterility Test	Sterile
Bacterial Endotoxins	< 0.25 IU/mg
Particulate Matter	Meets USP <788> requirements for small volume injections

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