Description

Cloxacillin Sodium Ep Impurity B (Mixture Of Diastereomers) is a defined chemical impurity used as a critical reference standard in pharmaceutical quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the manufacturing and stability testing of Cloxacillin Sodium, a semi-synthetic penicillin antibiotic. It is primarily required by pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) involved in analytical method development, validation, and regulatory compliance for antibiotic products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for calibrating analytical instruments and validating testing methods per ICH guidelines.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance: Critical for the routine batch testing of Cloxacillin Sodium API and finished drug products to ensure impurity levels are within specified limits.
• Regulatory Submission & Compliance: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Stability Studies: Employed to track the formation and increase of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification steps to minimize the formation of this impurity.

Basic Information

Product Name	Cloxacillin Sodium Ep Impurity B (Mixture Of Diastereomers)
CAS No.	1642559-64-5
Molecular Formula	C19H17ClN3NaO5S
Molecular Weight	457.86 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-(2-Chlorophenyl)-2-[[(3S)-3-methyl-4-oxo-1-sulfo-2-azetidinyl]carbamoyl]acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Sodium Salt (Mixture of Diastereomers); Cloxacillin EP Impurity B; Cloxacillin Sodium Isomer Impurity; 5R,6R-Cloxacillin Sodium Epimer B; Sodium (6R,7R)-7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Impurity; Cloxacillin Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Cloxacillin Sodium Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (EP, USP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Optical Rotation	Contact for details

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