Description

Mycophenolic Acid Impurity 3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Mycophenolic Acid and its related pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Mycophenolic Acid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor and control impurity levels against established specifications.
• Regulatory Compliance and Submissions: Essential for generating data required for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Mycophenolic Acid formulations.
• Research and Development (R&D): Supports chemical and pharmacological research into the metabolism, degradation pathways, and synthesis of Mycophenolic Acid and its analogs.

Basic Information

Product Name	Mycophenolic Acid Impurity 3
CAS No.	2390035-84-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	MPA Impurity 3; Mycophenolate Impurity 3; Mycophenolic Acid Related Compound 3; (E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid (tentative); Mycophenolic Acid Degradant; Mycophenolic Acid Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Mycophenolic Acid Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, GC, and MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment and handled with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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