Description

o-Desmethyl Mycophenolate Mofetil (Impurity A) is a key pharmaceutical impurity and metabolite of the immunosuppressant drug Mycophenolate Mofetil. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for research, quality control, and regulatory compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity A in Mycophenolate Mofetil drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradant.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure product purity and compliance with pharmacopeial specifications (USP, EP).
• Metabolite Research: Used in preclinical and clinical studies to understand the pharmacokinetics and metabolism of Mycophenolate Mofetil.
• Regulatory Submissions: Critical for compiling impurity profiles in regulatory filings (e.g., ANDA, NDA) for health authorities like the FDA and EMA.

Basic Information

Item	Detail
Product Name	o-Desmethyl Mycophenolate Mofetil (Impurity A)
CAS No.	1322681-36-6
Molecular Formula	C22H25NO7
Molecular Weight	415.44 g/mol
Synonyms	Mycophenolate Mofetil Impurity A; Mycophenolate Mofetil Related Compound A; 2-Morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate; MMF Impurity A; MPA Mofetil Impurity; 7-O-Desmethyl Mycophenolate Mofetil; Mycophenolic Acid Mofetil Impurity
EINECS	Contact for details

Quality Control

Our o-Desmethyl Mycophenolate Mofetil (Impurity A) is manufactured under controlled conditions and subjected to rigorous analytical testing. Quality is assured through comprehensive characterization using techniques like HPLC, LC-MS, NMR, and IR spectroscopy. We provide Certificates of Analysis (COA) with each batch, detailing purity, identity, and impurity profiles. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
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.