Memantine HCl
| Nazwa produktu | Memantine HCl |
|---|---|
| Numer CAS | 41100-52-1 |
| Wzór cząsteczkowy | C12H21N·HCl |
| Masa cząsteczkowa | 215.76 g/mol |
| Wygląd | Biały lub prawie biały krystaliczny proszek |
| Oznaczenie (HPLC) | 98.0% – 102.0% |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 20 ppm |
| Opakowanie | Beczka na włókna o pojemności 25 kg z podwójną wkładką z polietylenu |
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Synonimy: 1-Amino-3,5-dimethyladamantane hydrochloride, 3,5-Dimethyl-1-adamantanamine hydrochloride, Memantine hydrochloride, Namenda, Axura, Ebixa, D-145
Memantine HCl is the hydrochloride salt of memantine, a low-affinity uncompetitive antagonist of the NMDA receptor. Unlike other adamantane derivatives such as amantadine, memantine carries two methyl groups on the adamantane cage, a modification that fine-tunes its binding kinetics and improves tolerability. First approved in Europe in the 1990s and later in the United States under the brand Namenda, it has become a mainstay in the management of moderate-to-severe Alzheimer’s disease.
In terms of chemical behavior, memantine HCl is a white crystalline solid that is freely soluble in water and in ethanol, but practically insoluble in nonpolar solvents. Its pKa of approximately 10.3 means the amine is protonated at physiological pH, which limits passive diffusion across membranes but supports its use as a well-behaved salt form for oral solid dosage. The molecule is stable under ordinary storage conditions, though it should be protected from excessive moisture and heat.
For formulators, the salt form offers advantages over the free base: better aqueous solubility, improved handling, and more consistent dissolution profiles. It is commonly used in immediate-release tablets, extended-release capsules, and oral solutions. The active pharmaceutical ingredient is also investigated in combination products and in generic development programs targeting the growing dementia care market.
| Parametr | Specyfikacja |
|---|---|
| Oznaczenie (HPLC) | 98.0% – 102.0% |
| Identyfikacja | IR and HPLC retention time match reference standard |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 20 ppm |
| Wartości graniczne dla mikroorganizmów | Total aerobic count ≤ 1000 CFU/g; yeast and mold ≤ 100 CFU/g; absence of E. coli and Salmonella |
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