Description

Cefixime Impurity A CAS NO 1614255-90-1 is a high-purity chemical reference standard specifically identified as a process-related impurity of the antibiotic Cefixime. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily utilized by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Cefixime to ensure final product safety and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of Cefixime Impurity A in active pharmaceutical ingredient (API) batches.
• Essential for analytical method development and validation (HPLC, UPLC) in compliance with ICH Q2(R1) and other regulatory guidelines.
• Critical component in pharmaceutical quality control (QC) and stability studies to monitor impurity profiles.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development for optimizing Cefixime synthesis pathways and impurity fate studies.
• Valuable for calibrating laboratory instrumentation to ensure accurate and reproducible analytical results.

Basic Information

Product Name	Cefixime Impurity A
CAS No.	1614255-90-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(carboxymethoxy)iminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefixime Related Compound A; Cefixime EP Impurity A; Cefixime USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Cefixime Impurity A is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR), to ensure compliance with pharmacopeial standards (USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider conditions of 2-8°C.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.