Description

Oxacillin Sodium Impurity G(Ep) CAS NO 724695-30-1 is a high-purity chemical reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of the β-lactam antibiotic Oxacillin Sodium by enabling the accurate identification and quantification of a key process-related impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory compliance teams focused on method development, validation, and batch release testing.

Application

• Primary use as a certified reference standard (CRS) for the analysis of Oxacillin Sodium drug substance and finished products.
• Critical component in analytical method development and validation for impurity profiling in accordance with ICH guidelines.
• Used for system suitability testing and calibration of HPLC, UPLC, and other chromatographic systems.
• Essential for pharmacopoeial testing to comply with EP, USP, and other international monographs.
• Supports stability studies and forced degradation studies to understand impurity pathways.
• Vital raw material for manufacturers of impurity standards and working standards supplied to testing laboratories.
• Used in regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and control strategies.

Basic Information

Product Name	Oxacillin Sodium Impurity G(Ep)
CAS No.	724695-30-1
Molecular Formula	C19H18N3NaO5S
Molecular Weight	423.42 g/mol
Synonyms	(2S,5R,6R)-3,3-Dimethyl-6-[(5-methyl-3-phenyl-1,2-oxazole-4-carbonyl)amino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt; Oxacillin EP Impurity G; Oxacillin Sodium EP Impurity G; Oxacillin Related Compound G; Sodium (2S,5R,6R)-3,3-dimethyl-6-[[(5-methyl-3-phenylisoxazole-4-yl)carbonyl]amino]-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
EINECS	Contact for details

Quality Control

Every batch of Oxacillin Sodium Impurity G(Ep) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC). Certificates of Analysis (COA) providing batch-specific data are available upon request, supporting your GMP and regulatory documentation requirements.

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 must 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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