Memantine Hydrochloride
A potent uncompetitive NMDA receptor antagonist pivotal in modulating glutamatergic dysfunction, serving as a cornerstone API for Alzheimer's disease management.
CAS Number
41100-52-1
Formula
C₁₂H₂₁N·HCl
Mol. Weight
215.76 G/MOL
Grade
USP / EP / IP
Product Overview
Memantine Hydrochloride stands as a highly significant active pharmaceutical ingredient utilized broadly in the therapeutic management of moderate to severe Alzheimer's disease. As a low-to-moderate affinity uncompetitive NMDA receptor antagonist, it effectively attenuates the neurotoxic effects of persistently elevated, pathological levels of glutamate, while maintaining the transient physiological activation of NMDA receptors required for memory and learning processes.
Available as a premium-grade powder, our Memantine HCl API is synthesized utilizing robust and validated continuous manufacturing techniques ensuring rigorous removal of organic impurities, guaranteeing an API that surpasses the rigid standards outlined in major pharmacopeias.
Scale & Capacity
Commercial-scale production matching high-volume demands.
Custom Granulometry
Milled and micronized grades available globally.
API Snapshot
Pharmacodynamic Profile & Mechanism
Pathological Blockade
Memantine blocks the receptor's ion channel to prevent excessive calcium influx and resulting excitotoxicity associated with Alzheimer's continuous overactivation.
Uncompetitive Antagonism
Features a unique voltage-dependency; it primarily binds to open channels during pathological continuous activation, acting as an uncompetitive antagonist.
Physiological Preservation
During high-burst synaptic transmission associated with normal learning, memantine rapidly unbinds, preserving essential cognitive firing patterns.
Pharmacokinetics
Absorption & Distribution
Rapid and complete absorption post-oral dosing with linear pharmacokinetics. Extensive tissue distribution reflecting a large volume of distribution (9–11 L/kg).
Metabolism
Undergoes limited hepatic metabolism; major circulating metabolites (N-gludantan conjugate, 6-hydroxy memantine) are pharmacologically inactive.
Excretion
Primarily eliminated via the renal route (57-82% unchanged). Elimination rate depends on urine pH. Terminal half-life is approximately 60 to 100 hours.
Therapeutic Applications
Moderate to Severe Alzheimer's
Primary indication for symptomatic treatment, improving cognitive and functional domains.
Vascular Dementia
Demonstrates clinical utility in stabilizing cognitive deficits in cerebrovascular disease.
Neuroprotective Protocols
Investigational use for shielding against glutamate-induced excitotoxicity in CNS trauma.
Glaucoma Management
Studied for neuroprotective effects on retinal ganglion cells in progressive neuropathies.
Formulation Advantages & Clinical Superiority
Memantine Hydrochloride's distinct uncompetitive mechanism and robust safety profile make it an exceptionally favorable API for neurological indications.
Uncompetitive NMDA receptor antagonism preserves physiological activation patterns
Favorable pharmacokinetic profile with high oral bioavailability
Long elimination half-life (60-100 hours) supporting convenient dosing regimens
Minimal drug-drug interactions, primarily excreted unchanged
Safe and synergistic when co-administered with acetylcholinesterase inhibitors
Proven tolerability and reduced incidence of adverse neurological effects compared to older agents
Detailed Specifications
Rigidly Compliant with Standard Pharmacopoeia (USP / EP)
| Sr. | Test Parameter | Global Specification Validation |
|---|---|---|
| 1 | Description | White to off-white crystalline powder |
| 2 | Solubility | Soluble in water, sparingly soluble in alcohol |
| 3 | Identification | IR spectrum conforms to reference standard (USP) |
| 4 | pH (1% solution) | 4.5 – 6.0 |
| 5 | Water Content (KF) | Not more than 0.5% |
| 6 | Residue on Ignition | Not more than 0.1% |
| 7 | Related Substances | Any individual impurity: NMT 0.1%, Total: NMT 0.5% |
| 8 | Assay | 99.0% – 101.0% (on anhydrous basis) |
Why Choose Our Phenytoin Sodium
Uncompromising Purity
Advanced synthesis and rigorous purification processes ensuring consistently high assay values and exceptionally low impurity profiles, exceeding pharmacopeial standards.
Global Supply Reliability
Robust supply chain architecture, ensuring uninterrupted global distribution for generic formulation manufacturers across varied regulatory regions.
Comprehensive Documentation
Full technical packages available including DMF access, multi-zone stability data, elemental impurities profile, and detailed Certificate of Analysis (CoA).
Regulatory Excellence
Manufactured in state-of-the-art WHO-GMP certified facilities with full compliance to ICH guidelines and recognized by major global regulatory agencies.
Industrial Packaging
Double-layered polyethylene bags inside standard 25 kg fiber or HDPE drums. Pre-sterilized packing environments ensure absolute sterility. Customizable packing dimensions upon request.
Storage Protocol
API remains highly stable when stored at controlled room temperature (20-25°C). Must be preserved in tight, light-resistant containers away from high humidity gradients.
Product Stability
Extensive real-time and accelerated stability studies establish a long shelf life of 48 months from the date of manufacture when stored per protocol guidelines.
Secure Your Supply of Memantine HCl
Partner with Jay Overseas for a dependable, high-purity supply chain. Request a quote or reach out to our pharmaceutical specialists for multi-pharmacopoeial technical data.
Legal Disclaimer: The product documentation and specifications listed above are designed strictly for B2B industrial usage by qualified pharmaceutical formulators and research laboratories. Memantine Hydrochloride API is not for direct administration to patients. Always refer to your regulatory framework and validated internal quality paradigms. All product parameters are subject to the latest Master Formulation Records and CoAs.