Description

Cefpodoxime Proxetil Impurity B is a specified impurity and degradation product of the third-generation cephalosporin antibiotic, Cefpodoxime Proxetil. This compound is critical for pharmaceutical research, development, and quality control, as its monitoring is essential for ensuring the purity, safety, and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, characterization, and quality assurance of Cefpodoxime Proxetil.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Cefpodoxime Proxetil in drug substances and finished products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to accurately detect and quantify this specific impurity.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Cefpodoxime Proxetil and establish appropriate shelf-life.
• Quality Control (QC) Testing: A critical component in routine QC testing of active pharmaceutical ingredients (APIs) to ensure compliance with pharmacopeial limits for related substances.
• Regulatory Submissions: Required for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Used in R&D to study the chemical behavior, synthesis pathways, and purification processes of Cefpodoxime Proxetil.

Basic Information

Product Name	Cefpodoxime Proxetil Impurity B
CAS No.	947692-14-0
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 B; Cefpodoxime Impurity B; Cefpodoxime Proxetil Related Compound B; 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-methylpyridinium; CPDX-P Impurity B
EINECS	Contact for details

Quality Control

Our Cefpodoxime Proxetil Impurity B is manufactured and handled under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data and confirms compliance with in-house specifications aligned with ICH guidelines. The material is suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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 unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.