Description

Mifamurtide CAS NO 83461-56-7 is a synthetic lipophilic muramyl dipeptide (MDP) analog and a potent immunomodulator. It is a critical active pharmaceutical ingredient (API) primarily used in the formulation of advanced cancer therapeutics. This compound is essential for pharmaceutical manufacturers and research institutions developing targeted immunotherapies, particularly for the treatment of osteosarcoma.

Application

• Primary Pharmaceutical Ingredient: As the active component in liposomal formulations for the treatment of non-metastatic, resectable osteosarcoma.
• Immunotherapy Research: Used in preclinical and clinical studies investigating macrophage activation and innate immune response modulation.
• Oncology Drug Development: A key intermediate in the R&D of novel immunostimulatory agents targeting various cancers.
• Advanced Formulation Studies: For the development of liposome-encapsulated or nanoparticle-based drug delivery systems to enhance bioavailability and targeting.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical production.

Basic Information

Product Name	Mifamurtide
CAS No.	83461-56-7
Molecular Formula	C59H100N6O19P2
Molecular Weight	1235.39 g/mol
Synonyms	L-MTP-PE; Liposomal MTP-PE; Muramyl Tripeptide Phosphatidylethanolamine; CGP 19835; CGP-19835A; MTP-PE; Mifamurtide Sodium; Junovan (brand name)
EINECS	Contact for details

Quality Control

Our Mifamurtide is manufactured under strict quality systems to meet the exacting standards for pharmaceutical active ingredients. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We ensure compliance with relevant ICH guidelines and can support regulatory filings with documentation for GMP-grade material.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below under an inert atmosphere (e.g., nitrogen or argon) due to its hygroscopic and easily oxidized nature. For long-term storage, desiccants are recommended. Allow the sealed container to reach room temperature before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	White to off-white powder or solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Bacterial Endotoxins	< 10.0 EU/mg

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