Description

Cefathiamidine Impurity 9 is a specified impurity and reference standard used in the analytical profiling and quality control of the antibiotic Cefathiamidine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical development, quality assurance, and regulatory compliance for method validation and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Cefathiamidine.
• Impurity Profiling: Used in HPLC, LC-MS, and other chromatographic methods to identify, monitor, and control the level of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.
• Stability Studies: Employed to track the formation of degradation products in Cefathiamidine under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Quality Control (QC) Testing: Used in routine QC laboratories to ensure batch-to-batch consistency and compliance with established specifications.
• Research and Development: Aids in synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Cefathiamidine Impurity 9
CAS No.	802887-17-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5aR,6R)-6-[[(2R)-2-Amino-2-phenylacetyl]amino]-5a,6-dihydro-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazine-1,7(4H)-dione; Cefathiamidine Related Compound; Cefathiamidine EP Impurity; Cefathiamidine USP Impurity; Cefathiamidine Degradant; Cefathiamidine Process Impurity; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Our Cefathiamidine Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and chromatographic data is provided with every shipment to support your regulatory and quality needs.

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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH Q3C

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