| Customization: | Available |
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| Powder: | Yes |
| Customized: | Customized |
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Product Name:Memantine HCl
Application
It is believed that too much stimulation of nerve cells by glutamate may be responsible for the degeneration of nerves that occurs in some neurological diseases such as Alzheimer's disease. Glutamate is produced and released by nerve cells in the brain. The released glutamate then travels to nearby nerve cells where it attaches to a receptor on the surface of the cells called the N-methyl-D-aspartate (NMDA) receptor.
Memantine HCL blocks this receptor and thereby decreases the effects of glutamate. It is thought that by blocking the NMDA receptor and the effects of glutamate, memantine may protect nerve cells from excess stimulation by glutamate.
Memantine Benefits
Memantine HCl is the HCl form of Memantine. Memantine is a well- known neuroprotective drug used for the treatment of Alzheimer's disease. It is believed to be the first neuroprotective drug that has achieve clinical approval by US FDA as well as European.
The development of Alzheimer's disease involves the misfolded mutant proteins such as β-amyloid peptide (Aβ, particularly Aβ1−42). These misfolded mutant protein can increase the NMDA response and further cause severe excitotoxicity.
Memantine suppresses this process through acting as the antagonist of the N-methyl-d- aspartate-sensitive glutamate receptor (NMDARs).
Memantine is also under investigation as a potential treatment for other kind of neurodegenerative disorders such as HIV-associated dementia, neuropathic pain, glaucoma, depression, Huntington's disease, ALS and movement disorders, among other.
Medical Use
Memantine is used to treat moderate-to-severe Alzheimer's disease, especially for people who are intolerant of or have a contraindication to AChE (acetylcholinesterase) inhibitors.One guideline recommends memantine or an AChE inhibitor be considered in people in the early-to-mid stage of dementia.
Memantine has been associated with a modest improvement; with small positive effects on cognition, mood, behavior, and the ability to perform daily activities in moderate-to-severe Alzheimer's disease. There does not appear to be any benefit in mild disease.
Memantine when added to donepezil in those with moderate-to-severe dementia resulted in "limited improvements" in a 2017 review. The UK National Institute of Clinical Excellence (NICE) issued guidance in 2018 recommending consideration of the combination of memantine with donepezil in those with moderate-to-severe dementia. Effects in autism are unclear. Recent scientific journal reports are showing guarded promise with severe obsessive compulsive disorder.
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Item |
Requirements |
Test Results |
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appearance |
White or almost white crystalline powder |
White crystalline powder |
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Identification |
IR |
Comply |
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Related substance |
1-methyladamantane ≤0.3% 1,3,5 -trimethyladamantane ≤0.3% Unknow impuritiy ≤0.1% Total impurity ≤0.5% |
0.13% 0.14% <0.1% <0.4% |
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Residue on ignition |
≤0.1% |
0.06% |
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Heavy matal |
≤10ppm |
<10ppm |
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Loss on drying |
≤0.5% |
0.29% |
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Assay |
98.5-101.0% |
99.13% |
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Residual Solvents |
Ethyl Acetate: ≤0.5% Ethanol: ≤0.5% |
0.08% 0.12% |
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PH |
4.5-5.5 |
5.3 |
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Microbial Limits |
Max 5*102 aerobes and fungl per 1g E. Coli: Negative Salmonella: Negative
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Pass |
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Size of distributed particles |
Pass 100μ m |
Conforms |
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Conclusion |
Meet the requirements |
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