Description

Cefathiamidine Impurity 4 is a specified impurity of the antibiotic Cefathiamidine, identified by CAS NO 28307-26-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the parent drug substance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory compliance teams to ensure product purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cefathiamidine Impurity 4 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., ANDA, NDA, CTA) to support drug safety profiles.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Cefathiamidine, supporting formulation improvement and shelf-life extension.

Basic Information

Product Name	Cefathiamidine Impurity 4
CAS No.	28307-26-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-[(1-methyl-1H-tetrazol-5-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefathiamidine Related Compound; Cefathiamidine EP Impurity; Cefathiamidine USP Impurity; Cefathiamidine Degradant; Antibiotic Impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene derivative
EINECS	Contact for details

Quality Control

Our Cefathiamidine Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets high-purity standards suitable for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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