Description

Cefamandole Impurity 11 is a specified impurity and degradation product of the second-generation cephalosporin antibiotic, Cefamandole. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Cefamandole-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefamandole Impurity 11 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Assurance: Used in routine QC testing to ensure Cefamandole batches comply with pharmacopoeial limits (e.g., USP, EP, ICH Q3A/B) for specified impurities.
• Stability Studies: Employed to identify and track degradation pathways of Cefamandole under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Synthesis: Serves as a starting material or intermediate for synthetic chemists studying the degradation chemistry or developing impurity synthesis routes.

Basic Information

Product Name	Cefamandole Impurity 11
CAS No.	108260-06-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3S,6R,7R)-7-[[(2R)-2-Mandelamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-3-methyl ester; Cefamandole related compound; Cefamandole degradation product; Cefamandole specified impurity; Mandeloyl-7-ACA derivative; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Cefamandole Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and relevant pharmacopoeial 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 material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storage under an inert atmosphere.

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%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% 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.