Description

Cefminox Sodium Impurity 3 is a specified impurity and reference standard used in the quality control of the antibiotic Cefminox Sodium. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily required for method validation, stability studies, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cefminox Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch release testing to ensure compliance with pharmacopoeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate control over the impurity profile of the drug substance.
• Research & Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the parent API.

Basic Information

Item	Details
Product Name	Cefminox Sodium Impurity 3
CAS No.	1420072-83-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefminox Impurity 3; Cefminox Sodium Related Compound 3; Cefminox EP Impurity C; Cefminox USP Impurity; (6R,7S)-7-[[(2S)-2-Amino-2-carboxyethyl]thio]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (putative); Cefminox degradation product; Cefminox process impurity.
EINECS	Contact for details

Quality Control

Our Cefminox Sodium Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference standard. 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 in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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