Description

Oxacillin Impurity 3 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 key reference standard for quality control and analytical method validation. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Oxacillin API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Oxacillin active pharmaceutical ingredient (API).
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Used to monitor the formation of degradation products in Oxacillin formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and specifications for drug master files (DMFs).
• Pharmacopoeial Testing: Employed in testing to meet the stringent purity criteria outlined in pharmacopoeias such as USP, EP, and BP.
• Research & Development: Facilitates research into the degradation pathways and stability profile of Oxacillin and related penicillin antibiotics.

Basic Information

Product Name	Oxacillin Impurity 3
CAS No.	21106-64-9
Molecular Formula	C19H19N3O5S
Molecular Weight	401.44 g/mol
Synonyms	(2S,5R,6R)-6-[[(2,6-Dimethoxyphenyl)carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 5-Methyl-3-phenyl-4-isoxazolylpenicillin Impurity; Oxacillin Related Compound C; Oxacillin EP Impurity C; Oxacillin USP Impurity; 6-APA derivative of Oxacillin; Penicillanic acid, 6-[[(2,6-dimethoxybenzoyl)amino]-3,3-dimethyl-7-oxo-
EINECS	Contact for details

Quality Control

Every batch of Oxacillin Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced analytical techniques including HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%

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