Description

Oxacillin Impurity 2 is a specified impurity and degradation product of the β-lactam antibiotic Oxacillin. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method validation and quality control. It is essential for laboratories and manufacturers involved in ensuring the purity, safety, and regulatory compliance of Oxacillin API and its formulations.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Oxacillin Active Pharmaceutical Ingredient (API).
• Critical component in analytical method development and validation (HPLC, LC-MS) for pharmaceutical quality control laboratories.
• Used in stability studies to monitor the degradation profile of Oxacillin under various storage conditions.
• Essential for regulatory compliance and documentation, supporting submissions to agencies like the FDA and EMA.
• Supports research and development of Oxacillin-based drugs, including generic formulations.
• Employed in pharmacopoeial testing to ensure Oxacillin batches meet USP/EP/BP monograph specifications.

Basic Information

Product Name	Oxacillin Impurity 2
CAS No.	62604-78-8
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 B; 5-Methyl-3-phenylisoxazole-4-carboxamido Penicillanic Acid; Oxacillin EP Impurity B; Oxacillin USP Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Oxacillin Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided to support your GMP and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive and should be handled accordingly 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 ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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