Description

Cefdinir Impurity J CAS NO 1450758-23-2 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the broad-spectrum cephalosporin antibiotic, Cefdinir. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control testing of the active pharmaceutical ingredient (API). It is an essential material for analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical and biotechnology industries who require reliable reference standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify Cefdinir Impurity J in drug substance and finished product analysis.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to monitor impurities during API synthesis and formulation.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure Cefdinir batches meet stringent pharmacopeial (e.g., USP, EP, JP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies and Forced Degradation Testing: Acts as a marker to track the formation of specific degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research on Synthesis Pathways and Process Optimization: Used by process chemists to study and minimize the formation of this impurity during the manufacturing process of Cefdinir.

Basic Information

Item	Details
Product Name	Cefdinir Impurity J
CAS No.	1450758-23-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5Z)-5-[(2-Amino-4-thiazolyl)(hydroxyimino)acetyl]amino-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Cefdinir E-isomer Oxime Impurity; Cefdinir Related Compound J; Cefdinir Oxime Impurity; (5Z)-5-[[(2-Amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Cefdinir Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters. We support compliance with ICH guidelines and can supply materials suitable for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing under inert atmosphere if specified.

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.