Description

Cefamandole Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Cefamandole by serving as a known benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on antibiotic development and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Cefamandole active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with pharmacopeial monographs (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products in Cefamandole formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Synthesis: Serves as a key intermediate or marker in chemical synthesis research aimed at process optimization and impurity fate and tolerance studies.

Basic Information

Item	Detail
Product Name	Cefamandole Impurity 13
CAS No.	62442-75-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mandol Impurity 13; Cefamandole Related Compound 13; (6R,7R)-7-[[(2R)-2-Hydroxy-2-phenylacetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefamandole EP Impurity C; Cefamandole USP Impurity; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Our Cefamandole Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. 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 or COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	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.