Description

Mycophenolate Mofetil Ep Impurity C (Z-Isomer) is a specific stereoisomeric impurity associated with the immunosuppressant drug Mycophenolate Mofetil. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control testing. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Mycophenolate Mofetil drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified reference material (CRM) for the identification and quantification of the Z-isomer impurity in Mycophenolate Mofetil.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and detect stereoisomeric impurities.
• Quality Control & Assurance: Employed in routine batch testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor impurity profiles and ensure compliance with pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic processes.

Basic Information

Product Name	Mycophenolate Mofetil Ep Impurity C (Z-Isomer)
CAS No.	2286278-51-9
Molecular Formula	C23H31NO7
Molecular Weight	433.50 g/mol
Synonyms	(4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid 2-morpholinoethyl ester; (Z)-Mycophenolate Mofetil Impurity C; Mycophenolate Mofetil Z-Isomer; Mycophenolate Mofetil Impurity 5 (Z-Form); EP Impurity C of Mycophenolate Mofetil; MMF Z-Isomer Impurity; 2-Morpholinoethyl (Z)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate
EINECS	Contact for details

Quality Control

Our Mycophenolate Mofetil Ep Impurity C (Z-Isomer) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. We provide comprehensive Certificates of Analysis (COA) with batch-specific data, supporting compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards (EP, USP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

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 individual unspecified 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.