Description

Dicloxacillin is a semisynthetic, β-lactamase-resistant penicillin antibiotic. It is valued for its targeted efficacy against penicillinase-producing staphylococci, offering a critical therapeutic option for resistant bacterial infections. This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry developing oral dosage forms, such as capsules and tablets, for systemic antibacterial treatment.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of oral antibiotic medications.
• Antibacterial Formulations: Manufacture of capsules, tablets, and oral suspensions for treating infections caused by susceptible Gram-positive bacteria.
• Targeted Therapy: Specifically indicated for infections due to penicillinase-producing staphylococci, including skin and soft tissue infections.
• Veterinary Medicine: Potential use in veterinary pharmaceutical products for bacterial infections in animals.
• Research & Development: Serves as a reference standard and key intermediate in microbiological and pharmacological research.
• Combination Therapies: May be used in combination with other agents in clinical research for enhanced antibacterial spectra.

Basic Information

Product Name	Dicloxacillin
CAS No.	3116-76-5
Molecular Formula	C19H17Cl2N3O5S
Molecular Weight	470.33 g/mol
Synonyms	Dicloxacillin Sodium; Dicloxacillinum; BRL-1702; 6-[3-(2,6-Dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; (2S,5R,6R)-6-[[[3-(2,6-Dichlorophenyl)-5-methyl-4-isoxazolyl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; Stafoxil; Diclocil; Pathocil
EINECS	221-490-7

Quality Control

Our Dicloxacillin is produced and tested to meet high-purity standards suitable for pharmaceutical applications. Quality assurance includes rigorous analytical testing against established pharmacopeial specifications (such as USP/EP) for identity, potency, and purity. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with each batch to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-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)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

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