Description

Mycophenolate Mofetil n-Oxide (Ep Impurity G) is a critical pharmaceutical reference standard and impurity used in the quality control of Mycophenolate Mofetil, a key immunosuppressive drug. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a marker for specific degradation pathways. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing. The precise characterization of this impurity is vital for meeting stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity G in Mycophenolate Mofetil drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance purity meets EP, USP, or other pharmacopeial specifications.
• Stability Studies: Used to track the formation of this specific oxidative degradation product over time under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity profiling, degradation pathway studies, and the synthesis of related compounds in pharmaceutical R&D.

Basic Information

Product Name	Mycophenolate Mofetil n-Oxide (Ep Impurity G)
CAS No.	224052-51-1
Molecular Formula	C24H31NO8
Molecular Weight	461.50 g/mol
Synonyms	Mycophenolate Mofetil N-Oxide; Mycophenolate Mofetil Impurity G; Mycophenolate Mofetil EP Impurity G; (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-(morpholin-4-ium-4-yl)methyl-6-hexenoate N-oxide; 2-Morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate N-oxide; MMF N-Oxide; MMF Impurity G
EINECS	Contact for details

Quality Control

Our Mycophenolate Mofetil n-Oxide (Ep Impurity G) is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to confirm identity, purity, and potency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results against relevant specifications. We support compliance with EP, USP, and ICH Q3A/B guidelines for impurities.

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. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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