Description

Cefaclor, δ-3-Isomer (30 Mg) is a specific isomeric form of the second-generation cephalosporin antibiotic, cefaclor, distinguished by its precise chemical configuration. This high-purity reference standard is critical for analytical research, method development, and quality control in pharmaceutical manufacturing, ensuring the accurate identification and quantification of the active pharmaceutical ingredient and its related substances. It is an essential material for research scientists, analytical laboratories, and quality assurance departments within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified primary standard for calibrating analytical instruments and validating testing methods in QC/QA labs.
• Impurity Profiling and Identification: Used to identify, characterize, and quantify the δ-3-isomer and related impurities in cefaclor drug substance and finished dosage forms.
• Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for cefaclor-based products.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive proof of substance identity and purity for stability studies and batch release.
• Academic and Clinical Research: Utilized in pharmacokinetic, metabolic, and degradation pathway studies to understand the behavior of specific cefaclor isomers.

Basic Information

Product Name	Cefaclor, δ-3-Isomer (30 Mg)
CAS No.	152575-13-8
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 (δ-3-Isomer); Cefaclor δ-3-Isomer; Cefaclor Impurity F (δ-3-Isomer); 3-Cefaclor; (6R,7R)-7-[(R)-2-Amino-2-phenylacetamido]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

This analytical standard is manufactured under strict quality control conditions to ensure the highest purity and batch-to-batch consistency, suitable for use as a reference material. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identification tests, and chromatographic data. Our quality system is designed to meet the rigorous demands of pharmaceutical research and regulatory compliance.

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) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to high humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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