Description

o-Methyl Mycophenolate Mofetil (Ep Impurity D) CAS NO 1322681-37-7 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 analytical method development, validation, and ensuring the purity and safety of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality assurance, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of o-Methyl Mycophenolate Mofetil impurity in Mycophenolate Mofetil API and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	o-Methyl Mycophenolate Mofetil (Ep Impurity D)
CAS No.	1322681-37-7
Molecular Formula	C24H31NO7
Molecular Weight	445.51 g/mol
Synonyms	Mycophenolate Mofetil Impurity D; Mycophenolate Mofetil EP Impurity D; Mycophenolate Mofetil Related Compound D; (E)-6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid 2-Morpholinoethyl Ester; 2-Morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
EINECS	Contact for details

Quality Control

Our o-Methyl Mycophenolate Mofetil (Ep Impurity D) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with major pharmacopeias, including EP and USP.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry environment.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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