Description

Cefixime Impurity CAS NO 33748-00-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Cefixime. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling. The material is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Cefixime API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial standards (USP, EP, JP).
• Stability Studies: Used to track the formation of degradation products in Cefixime formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates studies on the synthesis, degradation pathways, and metabolism of Cefixime.

Basic Information

Item	Details
Product Name	Cefixime Impurity
CAS No.	33748-00-4
Molecular Formula	C16H15N5O7S2
Molecular Weight	453.45 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefixime Related Compound; Cefixime EP Impurity; Cefixime USP Impurity; Cefixime Degradant; (Z)-Isomer of Cefixime; Cefixime Analog
EINECS	Contact for details

Quality Control

Every batch of Cefixime Impurity (CAS 33748-00-4) is manufactured under controlled conditions and undergoes rigorous analytical testing. Our quality assurance protocol is designed to meet the exacting standards of pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity content by validated methods such as HPLC and NMR. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

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%
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.