Description

Methyl Mycophenolate (Ep Impurity E) is a high-purity pharmaceutical reference standard and a critical process-related impurity. This compound is essential for the analytical method development and validation required in the manufacturing and quality control of Mycophenolate Mofetil and related active pharmaceutical ingredients (APIs). It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development, production, and regulatory compliance of immunosuppressant drugs, ensuring the safety and efficacy of the final medicinal products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for quantitative and qualitative analysis in compliance with pharmacopeial guidelines (EP, USP).
• Analytical Method Development: Used to develop, validate, and calibrate HPLC, UPLC, and GC methods for impurity profiling.
• Quality Control & Assurance: Critical for monitoring and controlling the level of this specific impurity during the synthesis and purification of Mycophenolate Mofetil API.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and quantify degradation products.
• Process Chemistry Research: Used by chemists to study reaction pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Product Name	Methyl Mycophenolate (Ep Impurity E)
CAS No.	31858-66-9
Molecular Formula	C18H22O7
Molecular Weight	350.36 g/mol
Synonyms	Mycophenolate Methyl Ester; Mycophenolic Acid Methyl Ester; (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid Methyl Ester; Methyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxoisobenzofuran-5-yl)-4-methylhex-4-enoate; EP Impurity E of Mycophenolate Mofetil; Mycophenolate Mofetil Impurity E
EINECS	Contact for details

Quality Control

Every batch of Methyl Mycophenolate (Ep Impurity E) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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