Description

Cefpodoxime Proxetil Ep Impurity F CAS NO 96680-30-7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic Cefpodoxime Proxetil by serving as a known benchmark in chromatographic analysis. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Cefpodoxime Proxetil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development & Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches of Cefpodoxime Proxetil comply with stringent pharmacopeial specifications (e.g., EP, USP, JP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) to determine drug shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Product Name	Cefpodoxime Proxetil Ep Impurity F
CAS No.	96680-30-7
Molecular Formula	C21H27N5O9S2
Molecular Weight	557.60 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid 1-(Isopropoxycarbonyloxy)ethyl Ester; Cefpodoxime Impurity F; Cefpodoxime Proxetil Related Compound F; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl] 1-Isopropoxycarbonyloxyethyl Ester
EINECS	Contact for details

Quality Control

Every batch of Cefpodoxime Proxetil Ep Impurity F is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques to confirm identity and purity, aligning with pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and identification. Our quality commitment ensures the material is suitable for its intended use in regulated pharmaceutical analysis.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid exposure to excessive heat and humidity.

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)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
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.