Description

Mycophenolic Acid Lactone (Ep Impurity H) is a critical pharmaceutical reference standard and impurity used in the development and quality control of immunosuppressant drugs. Its primary value lies in ensuring the purity, safety, and regulatory compliance of active pharmaceutical ingredients (APIs) like Mycophenolate Mofetil. This compound is essential for analytical laboratories, pharmaceutical manufacturers, and research institutions focused on method validation and impurity profiling. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards for drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods in QC laboratories.
• Impurity Profiling & Control: Used for the identification, quantification, and monitoring of process-related impurities in Mycophenolate Mofetil and Mycophenolic Acid APIs.
• Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis as per ICH guidelines.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track impurity formation and degradation pathways in drug substances and products under various stability conditions.
• Research & Development: Used in synthetic chemistry and pharmacology research to study the metabolism and degradation of mycophenolate-based therapeutics.

Basic Information

Product Name	Mycophenolic Acid Lactone (Ep Impurity H)
CAS No.	79081-87-1
Molecular Formula	C17H18O6
Molecular Weight	318.32 g/mol
Synonyms	Mycophenolic Acid Lactone; (4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic Acid; Mycophenolate Lactone; Ep Impurity H of Mycophenolate Mofetil; Impurity H (Mycophenolate Mofetil); 5,7-Dihydroxy-4-methyl-6-(4-methyl-3-pentenyl)-3H-isobenzofuran-1-one; 6-(1,3-Dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoic Acid δ-Lactone
EINECS	Contact for details

Quality Control

Our Mycophenolic Acid Lactone (Ep Impurity H) is manufactured under strict quality systems to ensure it meets the exacting requirements for pharmaceutical impurity standards. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, test results, and chromatograms. Our quality commitment aligns with the standards expected for pharmacopeial (USP/EP) reference materials and supports cGMP compliance for our partners in regulated markets.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container tightly sealed in a dry environment.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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