Description

Sodium Cloxacillin Monohydrate CAS NO 7081-44-9 is a semisynthetic, β-lactamase-resistant penicillin antibiotic in its sodium salt form. 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 antibiotic formulations to treat serious bacterial infections. Its stability and potency make it a key component in both human and veterinary medicine.

Application

• Primary Active Pharmaceutical Ingredient (API) in the manufacture of sterile injectable antibiotic solutions.
• Core component in the formulation of oral antibiotic capsules and tablets for clinical use.
• Used in veterinary pharmaceuticals for the treatment of bacterial infections in livestock and companion animals.
• Critical raw material for research and development of new antibiotic combinations and delivery systems.
• Reference standard in quality control laboratories for analytical method development and validation.
• Intermediate in the synthesis of more complex antibiotic derivatives for specialized applications.

Basic Information

Product Name	Sodium Cloxacillin Monohydrate
CAS No.	7081-44-9
Molecular Formula	C19H17ClN3NaO5S • H2O
Molecular Weight	475.87 g/mol
Synonyms	Cloxacillin Sodium Monohydrate; Sodium (2S,5R,6R)-6-[[[3-(2-Chlorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate Monohydrate; (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 Monohydrate; Cloxacillin Sodium Salt Hydrate; BRL-1621; Orbenin; Tegopen
EINECS	230-400-1

Quality Control

Our Sodium Cloxacillin Monohydrate is manufactured under strict quality systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with major pharmacopeial standards such as USP, EP, and BP. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, consider storage under an inert atmosphere.

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)	98.0% - 102.0% (on anhydrous basis)
pH (10% solution)	5.0 - 7.0
Water Content (KF)	3.0% - 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Specific Optical Rotation	+163° to +172°
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.25 EU/mg (for injectable grade)
Sterility	Conforms (for sterile grade)

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