Description

Cefaclor Impurity 11 CAS NO 51795-31-4 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Cefaclor. This compound is critical for pharmaceutical quality control, enabling manufacturers to monitor, identify, and quantify this specific impurity to ensure the purity and safety of the final drug product. It is an essential material for analytical laboratories, quality assurance departments, and research institutions involved in the development, production, and regulatory compliance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cefaclor Impurity 11 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Cefaclor API and formulations meet stringent pharmacopeial purity specifications (e.g., USP, EP, JP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Cefaclor.

Basic Information

Product Name	Cefaclor Impurity 11
CAS No.	51795-31-4
Molecular Formula	C15H14ClN3O4S
Molecular Weight	367.81 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; δ-3-Cefaclor; Cefaclor δ3-Isomer; 3-Cefaclor; Cefaclor Impurity C (EP); Cefaclor Related Compound C (USP); 3-Chlorocephem derivative of Cefaclor
EINECS	Contact for details

Quality Control

Every batch of Cefaclor Impurity 11 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with pharmacopeial guidelines.

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); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing 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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.