Description

Mycophenolate Sodium is the sodium salt form of the active metabolite of mycophenolate mofetil, a potent immunosuppressive agent. This compound is critical for the selective inhibition of inosine monophosphate dehydrogenase, a key enzyme in the de novo pathway of purine synthesis. It is primarily utilized in the formulation of pharmaceutical products for the prevention of organ transplant rejection and the treatment of autoimmune diseases. Our high-purity Mycophenolate Sodium CAS NO 37415-62-6 ensures reliable performance and consistency for advanced therapeutic applications.

Application

• Active Pharmaceutical Ingredient (API) in immunosuppressive medications for organ transplantation (kidney, heart, liver).
• Key intermediate in the synthesis of advanced immunosuppressant drugs and prodrugs.
• Research and development of novel therapies for autoimmune conditions like lupus and psoriasis.
• Formulation of enteric-coated tablets to improve gastrointestinal tolerance.
• Reference standard for quality control and analytical testing in pharmaceutical laboratories.
• Clinical trial material for investigational new drug (IND) applications.

Basic Information

Product Name	Mycophenolate Sodium
CAS No.	37415-62-6
Molecular Formula	C17H19NaO6
Molecular Weight	342.32 g/mol
Synonyms	Mycophenolic Acid Sodium Salt; Sodium Mycophenolate; Mycophenolate Sodium Salt; (E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic Acid Sodium Salt; EC-MPS (Enteric-Coated Mycophenolate Sodium); MPA Sodium Salt; Mycophenolate Na; Mycophenolate Sodium (USP)
EINECS	Contact for details

Quality Control

Our Mycophenolate Sodium is manufactured under strict quality management systems. Each batch is tested to meet or exceed relevant pharmacopeial standards, including USP and EP monographs, ensuring identity, purity, strength, and composition. Comprehensive testing includes assay, related substances, residual solvents, and microbiological examination. A Certificate of Analysis (COA) documenting all test results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Limits	Complies with USP <61> and <62>

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