Description

Cefaclor Impurity G CAS NO 67308-21-8 is a specified impurity and reference standard used in the analytical profiling and quality control of the antibiotic Cefaclor. Its primary value lies in ensuring the purity, safety, and regulatory compliance of the active pharmaceutical ingredient (API). This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on method development, stability studies, and meeting stringent pharmacopeial requirements for cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cefaclor Impurity G in bulk drug substances and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Cefaclor API and drug products meet specified impurity limits as per USP, EP, or other pharmacopeial monographs.
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Serves as a key intermediate or marker in studies investigating the synthesis, degradation pathways, and metabolism of Cefaclor.

Basic Information

Product Name	Cefaclor Impurity G
CAS No.	67308-21-8
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; 3-Chloro-7-D-phenylglycylamido-3-cephem-4-carboxylic acid; δ-3-Cefaclor; Cefaclor δ-3-Isomer; Cefaclor Impurity C (EP); Cefaclor Related Compound G (USP); 3-Cefaclor
EINECS	Contact for details

Quality Control

Every batch of Cefaclor Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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