Description

Mycophenolate Mofetil Related Compound B [(Rs)-7-Hydroxy-5-Methoxy-4-Methyl-6-[2-(5-Methyl-2-Oxo-Tetrahydrofuran-5-Yl)Ethyl]-3H-Isobenzofuranyl-1-One] is a key impurity and reference standard used in the quality control of the immunosuppressant drug Mycophenolate Mofetil. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Mycophenolate Mofetil formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Mycophenolate Mofetil API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Stability Studies: Used to monitor the formation of degradation products in Mycophenolate Mofetil under various storage conditions as part of ICH stability-indicating methods.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive proof of impurity profiling and control strategies for drug substance specifications.
• Pharmacopoeial Testing: Employed in testing to meet the stringent purity criteria outlined in pharmacopoeial monographs such as USP, EP, and JP.
• Research & Development: Utilized in preclinical and clinical research to understand the metabolic pathways and impurity profiles of Mycophenolate Mofetil.

Basic Information

Product Name	Mycophenolate Mofetil Related Compound B [(Rs)-7-Hydroxy-5-Methoxy-4-Methyl-6-[2-(5-Methyl-2-Oxo-Tetrahydrofuran-5-Yl)Ethyl]-3H-Isobenzofuranyl-1-One]
CAS No.	26675-76-3
Molecular Formula	C20H22O7
Molecular Weight	374.39 g/mol
Synonyms	(Rs)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one; Mycophenolate Mofetil Impurity B; Mycophenolate Mofetil Related Substance B; 7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxotetrahydrofuran-5-yl)ethyl]-1,3-dihydroisobenzofuran-1-one; MMF Related Compound B; Mycophenolic Acid β-D-Glucoside Impurity B (related structure); RS-7-Hydroxy MPA Lactone Derivative
EINECS	Contact for details

Quality Control

Our Mycophenolate Mofetil Related Compound B is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory and compliance needs.

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 light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment away from direct light exposure 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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.