Memantine Hydrochloride is a synthetic aminoadamantane derivative functioning as a low-affinity voltage-dependent uncompetitive NMDA receptor antagonist. It modulates the pathological effects of basal tonic levels of glutamate, preventing neuronal dysfunction in neurodegenerative conditions. Produced via strictly controlled multi-step organic synthesis and purification processes, this active pharmaceutical ingredient serves as the core raw material for formulating oral medications prescribed for Alzheimer's disease management. The compound is isolated as a white crystalline powder, optimized for solid dosage manufacturing requiring high chemical stability and precise content uniformity.
Product Information
|
Parameter |
Specification Details |
|
International Nonproprietary Name |
Memantine Hydrochloride |
|
Chemical Name |
3,5-dimethyladamantan-1-amine hydrochloride |
|
CAS Registry Number |
41100-52-1 |
|
Molecular Formula |
C12H21N.HCl |
|
Molecular Weight |
215.76 g/mol |
|
Structural Formula |
Tricyclic amine hydrochloride derivative |
|
Therapeutic Category |
Central Nervous System Agent; NMDA Receptor Antagonist |
|
Pharmacopeial Status |
Conforms to USP and EP standards |
Quality & Specification
|
Test Parameter |
Acceptance Criteria |
Analytical Method |
|
Appearance |
White crystalline powder |
Visual Inspection |
|
Identity |
Infrared spectrum matches reference standard |
FTIR and HPLC |
|
Assay (Dried basis) |
99.0% to 101.5% |
Titration and HPLC |
|
Melting Range |
Above 300°C with decomposition |
Capillary Melting Point |
|
Loss on Drying |
Maximum 0.5% |
Gravimetric Analysis (105°C, 3h) |
|
Residue on Ignition |
Maximum 0.1% |
Platinum Crucible Incineration |
|
Heavy Metals |
Maximum 10 ppm |
Colorimetry and ICP-MS |
|
Individual Impurity |
Maximum 0.10% |
Gradient HPLC |
|
Total Impurities |
Maximum 0.50% |
Gradient HPLC |
|
Residual Solvents |
Complies with ICH Q3C limits |
Headspace GC |
|
Particle Size Distribution |
Customization available for micronized grades |
Laser Diffraction |
Manufacturing & Supply
Synthesis Route: Proprietary catalytic amination and salification pathway
Cleanroom Classification: ISO 8 synthesis zones with ISO 5 containment areas for final crystallization and isolation
Batch Capability: Industrial scale production per campaign with verified batch-to-batch reproducibility
In-Process Controls: Continuous online monitoring of reaction temperature, pressure, pH, and intermediate purity
Supply Continuity: Dual-sourcing framework for critical starting materials and validated safety stock protocols
Documentation
Regulatory Dossier: Comprehensive Drug Master File available for regulatory review
Certificate of Analysis: Supplied with every commercial and sample batch detailing analytical values
Quality Compliance: Written Confirmation for active substances exported to the European Union
Toxicological Data: Genotoxicity, impurity profile assessment, and residual solvent validation reports
Stability Data: Long-term (25°C / 60% RH) and accelerated (40°C / 75% RH) stability packages
Supply Chain Statements: BSE-free certification, GMO-free statement, and melamine-free confirmation
Packaging
|
Primary Packaging |
Food-grade double-layer low-density polyethylene bags, heat-sealed under vacuum |
|
Secondary Packaging |
Rigid fiber drum providing mechanical protection |
|
Desiccant Placement |
Food-grade silica gel sachet positioned between primary and secondary packaging layers |
|
Standard Net Weight |
25 kg per drum (Customizable packaging sizes available upon technical agreement) |
|
Storage Condition |
Store in a tightly closed container, protected from light, moisture, and excessive heat (15°C to 30°C) |
Pharmaceutical Application
Oral Solid Dosage Formulations: Serves as the primary active pharmaceutical ingredient for manufacturing immediate-release and extended-release film-coated tablets, ensuring consistent active content per tablet for precise dosing requirements.
Neurodegenerative Disease Management: Utilized in drug products targeting moderate to severe stages of Alzheimer's type dementia, providing necessary chemical purity and structural stability for central nervous system receptor interactions.
Combination Therapies: Incorporated into multi-ingredient regimen development alongside acetylcholinesterase inhibitors, maintaining compatibility with standard excipients and stabilizing agents during solid-state blending and granulation.
Generic Formulation Development: Applied by generic drug manufacturers seeking bioequivalent alternative sources to reference listed drugs, facilitating regulatory filing through established pharmacopeial compliance.
FAQ
Q: What pharmacopeial standards does Memantine Hydrochloride comply with?
A: The product is manufactured, tested, and released in strict compliance with current United States Pharmacopeia and European Pharmacopoeia monographs.
Q: Is a Drug Master File accessible for regulatory submission?
A: Yes, an active Drug Master File is maintained and available for reference to support customer regulatory filings in regulated markets upon execution of a confidentiality agreement.
Q: What is the standard commercial shelf life and recommended storage condition?
A: The established shelf life is 36 months from the date of manufacture when stored in original unopened containers under controlled room temperature conditions between 15°C and 30°C, protected from direct light and moisture.
Q: Can particle size distribution be adjusted for direct compression processes?
A: Yes, micronization and customized particle size distribution specifications can be accommodated via validated jet milling processes to meet specific direct compression or granulation requirements.
Q: How are process-related and genotoxic impurities controlled?
A: Impurities are monitored via validated high-performance liquid chromatography and gas chromatography methods, maintaining individual and total impurity levels well below qualification thresholds.
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