Venlafaxine HCl
| Nazwa produktu | Venlafaxine HCl |
|---|---|
| Numer CAS | 99300-78-4 |
| Wzór cząsteczkowy | C17H27NO2·HCl |
| Masa cząsteczkowa | 313.86 g/mol |
| Wygląd | Biały lub prawie biały krystaliczny proszek |
| Oznaczenie (HPLC) | 98.0% – 102.0% (on dried basis) |
| Rozpuszczalność | Soluble in water, methanol; slightly soluble in ethanol |
| Przechowywanie | Store in tight containers, protected from light |
| Opakowanie | 25 kg fiber drum with double polyethylene liners |
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Synonimy: (±)-1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride, Wy-45030, Venlafaxine hydrochloride, Effexor, Trevilor, Dobupal
Venlafaxine HCl is the hydrochloride salt of venlafaxine, a bicyclic phenylethylamine derivative that acts as a serotonin-norepinephrine reuptake inhibitor (SNRI). First approved in the 1990s, it has become a mainstay in the treatment of major depressive disorder, generalized anxiety disorder, and panic disorder. Its distinct pharmacological profile—weak dopamine reuptake inhibition at higher doses—sets it apart from selective serotonin reuptake inhibitors (SSRIs).
Chemically, venlafaxine HCl is a racemic mixture of two enantiomers, with the (R)-enantiomer primarily responsible for norepinephrine reuptake inhibition and the (S)-enantiomer for serotonin reuptake inhibition. This dual action contributes to its broad efficacy across mood and anxiety disorders. The hydrochloride salt form offers improved aqueous solubility and stability, making it suitable for a range of immediate-release and extended-release oral dosage forms.
Manufacturers and CDMOs rely on venlafaxine HCl as a key API for generic formulations, particularly extended-release capsules and tablets. The compound is also a frequent subject in bioequivalence studies and analytical method development, given its well-characterized pharmacokinetics and established therapeutic window. Its patent-expired status has made it a high-volume item in the global generic market.
| Parametr | Specyfikacja |
|---|---|
| Oznaczenie (HPLC) | 98.0% – 102.0% |
| Identyfikacja | IR, HPLC retention time conforms to 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 & Mold ≤ 100 CFU/g; E. coli absent |
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