Description

Oxacillin Impurity F is a specified impurity and degradation product of the antibiotic Oxacillin Sodium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and analytical method validation. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure the purity, safety, and efficacy of Oxacillin API and its formulations.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Oxacillin Sodium API and finished drug products.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical quality control laboratories.
• Used in stability studies to monitor the degradation profile of Oxacillin under various storage conditions.
• Critical component for regulatory compliance and filing, supporting ICH guidelines (Q3A, Q3B) on impurities in new drug substances and products.
• Supports pharmacopoeial testing and helps manufacturers meet standards set by USP, EP, and other international pharmacopoeias.
• Valuable for research into degradation pathways and the synthesis of related penicillin compounds.

Basic Information

Product Name	Oxacillin Impurity F
CAS No.	5053-35-0
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-isoxazolyl Penicillin Impurity F; Oxacillin Related Compound F; 6-APA Derivative Impurity; Penicillin Impurity
EINECS	Contact for details

Quality Control

Every batch of Oxacillin Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial and ICH standards. 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 a 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%
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.