Description

Cefpodoxime Proxetil Impurity D 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 certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Cefpodoxime Proxetil API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity D in Cefpodoxime Proxetil drug substance and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC labs to confirm impurity levels comply with pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies & Forced Degradation: Employed to identify and characterize degradation pathways of Cefpodoxime Proxetil under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTD), and regulatory filings to agencies like the FDA and EMA.
• Research on Degradation Mechanisms: Supports fundamental research into the chemical stability and decomposition kinetics of cephalosporin antibiotics.

Basic Information

Product Name	Cefpodoxime Proxetil Impurity D
CAS No.	947692-13-9
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; Cefpodoxime Impurity D; Cefpodoxime Acid; Cefpodoxime Free Acid; De-esterified Cefpodoxime Proxetil; (6R,7R)-7-[2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Cefpodoxime Proxetil Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (IR, MS, NMR), to ensure identity, potency, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting its use as a high-grade reference standard for pharmaceutical applications.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

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%
Residue on Ignition	≤ 0.5%

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