Description

Oxacillin Sodium Impurity D(Ep) is a specified impurity and degradation product of the β-lactam antibiotic Oxacillin Sodium. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for laboratories and manufacturers focused on ensuring the purity, safety, and regulatory compliance of Oxacillin Sodium API and its finished dosage forms. Professionals in pharmaceutical quality assurance, analytical chemistry, and regulatory affairs require this high-purity standard to meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Oxacillin Sodium Impurity D(Ep) in active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Oxacillin Sodium and related penicillin drugs.
• Quality Control & Batch Release: Used in routine QC testing of Oxacillin Sodium API to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Oxacillin Sodium.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity profiling, synthesis pathway optimization, and metabolite studies in antibiotic research.

Basic Information

Product Name	Oxacillin Sodium Impurity D(Ep)
CAS No.	1642559-63-4
Molecular Formula	C19H18N3NaO6S
Molecular Weight	439.42 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R,5R)-5-Methyl-3-(2-methyl-5-oxo-1-phenyl-4,5-dihydro-1H-pyrazol-4-yl)-1,3-oxazolidine-2-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt; Oxacillin EP Impurity D; Oxacillin Sodium EP Impurity D; Oxacillin Related Compound D (Epimer); Sodium (2S,5R,6R)-6-[[(2R,5R)-5-methyl-3-(2-methyl-5-oxo-1-phenyl-4,5-dihydro-1H-pyrazol-4-yl)-1,3-oxazolidine-2-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Oxacillin Sodium Impurity D(Ep) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including purity by HPLC, water content, residual solvents, and specific identification. We support compliance with ICH, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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