Description

Cefpodoxime Proxetil Impurity G is a specified impurity and degradation product of the broad-spectrum antibiotic Cefpodoxime Proxetil. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, quality control, and regulatory compliance. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cefpodoxime Proxetil drug substances and finished products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Cefpodoxime Proxetil API.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies to monitor degradation pathways and establish shelf-life for pharmaceutical formulations.
• Used for pharmacopoeial testing to comply with stringent standards set by USP, EP, and other international pharmacopoeias.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profile data for health authorities like the FDA and EMA.
• Valuable for research and development of new synthetic routes and purification processes for Cefpodoxime Proxetil.

Basic Information

Product Name	Cefpodoxime Proxetil Impurity G
CAS No.	947692-15-1
Molecular Formula	C21H27N5O9S2
Molecular Weight	557.60 g/mol
Synonyms	(6R,7R)-7-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetamido]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid 1-(Isopropoxycarbonyloxy)ethyl Ester Impurity G; Cefpodoxime Impurity G; Cefpodoxime Proxetil Related Compound G; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-2-yl]carbonyl]oxy]ethyl isopropyl carbonate; Cefpodoxime Proxetil EP Impurity G
EINECS	Contact for details

Quality Control

Our Cefpodoxime Proxetil Impurity G is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a reference standard for pharmacopoeial (USP/EP) compliance and regulatory submissions.

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 must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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%
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.