Description

(4Z)-Mycophenolate Mofetil (Ep Impurity C) CAS NO 1076198-64-5 is a critical isomer impurity of the immunosuppressant drug Mycophenolate Mofetil, specifically referenced in the European Pharmacopoeia (EP) as Impurity C. This compound is essential for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for impurity profiling, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the (4Z)-isomer impurity in Mycophenolate Mofetil drug substance and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity separation and detection.
• Quality Control & Batch Release Testing: Critical for routine quality control testing to ensure drug substance and product batches comply with EP, USP, or ICH impurity limits.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to study the pharmacokinetics, metabolism, and toxicity profile of this specific isomer.

Basic Information

Product Name	(4Z)-Mycophenolate Mofetil (Ep Impurity C)
CAS No.	1076198-64-5
Molecular Formula	C23H31NO7
Molecular Weight	433.49 g/mol
Synonyms	(4Z)-Mycophenolate Mofetil; Mycophenolate Mofetil Impurity C (EP); Mycophenolate Mofetil Z-Isomer; (Z)-Mycophenolate Mofetil; 2-Morpholinoethyl (4Z)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate; MMF Impurity C; Mycophenolate Mofetil Related Compound C
EINECS	Contact for details

Quality Control

Our high-purity reference standards are manufactured and tested under strict quality systems. Each batch of (4Z)-Mycophenolate Mofetil (Ep Impurity C) is characterized using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with pharmacopeial standards for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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 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.