Description

Cefathiamidine Impurity 6 is a specified impurity of the antibiotic Cefathiamidine, identified by the CAS registry number 28240-16-6. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this impurity during drug manufacturing. It is an essential material for quality assurance laboratories, analytical chemists, and regulatory affairs professionals working on cephalosporin antibiotic development and production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Quality Control & Assurance: Used in HPLC, LC-MS, and other chromatographic systems for the identification and quantification of Cefathiamidine Impurity 6 in active pharmaceutical ingredient (API) batches.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity profile data.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Cefathiamidine to minimize impurity formation.
• Pharmacopoeial Testing: Serves as a system suitability standard in testing protocols aligned with pharmacopoeial monographs.

Basic Information

Product Name	Cefathiamidine Impurity 6
CAS No.	28240-16-6
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; Antibiotic Impurity; Cephalosporin Impurity Standard
EINECS	Contact for details

Quality Control

Our Cefathiamidine Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles for reference standards.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.