Description

Dicloxacillin Ep Impurity B CAS NO 89353-77-5 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the antibiotic Dicloxacillin by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and compliance testing.

Application

• Primary use as a pharmaceutical reference standard for the analysis of Dicloxacillin sodium.
• Critical component in impurity profiling and method validation for regulatory submissions (e.g., ICH guidelines).
• Used in HPLC, LC-MS, and GC-MS systems for calibration and system suitability testing.
• Essential for stability studies and degradation pathway elucidation of β-lactam antibiotics.
• Supports quality control (QC) and quality assurance (QA) laboratories in pharmaceutical production.
• Valuable for research and development of new analytical methods for penicillin derivatives.

Basic Information

Product Name	Dicloxacillin Ep Impurity B
CAS No.	89353-77-5
Molecular Formula	C19H17Cl2N3O5S
Molecular Weight	470.33 g/mol
Synonyms	(2S,5R,6R)-6-[[[3-(2,6-Dichlorophenyl)-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; Dicloxacillin Related Compound B; Dicloxacillin Impurity B; 6-APA Dicloxacillin Impurity; EP Impurity B of Dicloxacillin
EINECS	Contact for details

Quality Control

Every batch of Dicloxacillin Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with European Pharmacopoeia (EP) and ICH guidelines for impurity standards. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided to guarantee traceability and reliability for your critical applications.

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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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