Description

Oxacillin Impurity 1 is a specified impurity of the β-lactam antibiotic Oxacillin, identified by the CAS registry number 36231-30-8. This compound is of critical importance in pharmaceutical development and quality control for ensuring the purity, safety, and efficacy of Oxacillin-based drug products. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Oxacillin drug substance and finished products.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of Oxacillin Impurity 1 under various stress conditions.
• Quality Control & Batch Release: Serves as a system suitability standard and an impurity marker in the routine quality control testing of Oxacillin active pharmaceutical ingredient (API).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research on Degradation Pathways: Used in research to elucidate the degradation mechanisms and kinetics of Oxacillin.

Basic Information

Product Name	Oxacillin Impurity 1
CAS No.	36231-30-8
Molecular Formula	C19H19N3O5S
Molecular Weight	401.44 g/mol
Synonyms	(2S,5R,6R)-6-[[(5-Methyl-3-phenyl-1,2-oxazol-4-yl)carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Oxacillin Related Compound A; Oxacillin EP Impurity A; 5-Methyl-3-phenylisoxazole-4-carboxamido penicillanic acid; Isoxazolyl Penicillin Impurity
EINECS	Contact for details

Quality Control

Our Oxacillin Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization by NMR and MS, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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