Description

(△2-Cefdinir) CAS NO 934986-49-9 is a key pharmaceutical intermediate and impurity standard, essential for ensuring the quality and safety of the third-generation cephalosporin antibiotic, Cefdinir. Its primary value lies in its critical role in analytical method development, stability studies, and regulatory compliance for pharmaceutical manufacturers. This compound is specifically needed by research and development laboratories, quality control departments, and active pharmaceutical ingredient (API) producers focused on cephalosporin-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Cefdinir API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific degradation product.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity material for specification setting and safety assessments.
• Research on Degradation Pathways: Used in academic and industrial research to study the chemical behavior and degradation mechanisms of Cefdinir.
• Calibration of Analytical Instruments: Serves as a precise calibrant to ensure the accuracy and reliability of analytical equipment used in pharmaceutical analysis.

Basic Information

Product Name	(△2-Cefdinir)
CAS No.	934986-49-9
Molecular Formula	C14H13N5O5S2
Molecular Weight	395.41 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; δ2-Cefdinir; Cefdinir δ2-Isomer; Cefdinir Impurity; Cefdinir Related Compound; (Z)-Cefdinir; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Our (△2-Cefdinir) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment, supporting GMP and ICH guideline compliance for impurity qualification.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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