Име на продукта: Pramipexole Hydrochloride
Синоними: PRAMIPEXOLE DIHYDROCHLORIDE; PRAMIPEXOLE HCL; (s)-2-amino-4,5,6,7-tetrahydro-6-(пропиламино)benzothiazole dihydrochloride; PramipexoleDihcl;
CAS: 104632-25-9
Степен: медицинска степен
Анализ: 99%
Молекулярна формула: C10H19Cl2N3S
Молекулно тегло: 284.25
Точка на топене: 288-290°C
Външен вид: бял кристален прах
Категория: pharmaceutical raw materials
Pramipexole hydrochloride is a kind of drugs for treatment of Parkinson syndrome. It belongs to selective non-ergot dopamine receptor agonist. It was first successfully developed by Boehringer Ingelheim Company (Germany). It is a prescription drugs of dopamine receptor agonist applied in the largest amount of the world. In May, 1997, it had been approved for the first time by FDA for the treatment of idiopathic Parkinson's disease. It can reduce the symptoms and sign, and can either be used alone or in combination with levodopa. The trade name of the good marketed in the United States is Mirapex, which is the first drugs approved the FDA during the past six years for treatment of Parkinson syndrome. In 2007, it has entered into market in China with the commodity name being sifrol for the treatment of the signs and symptoms of idiopathic Parkinson's disease, being used either alone (without levodopa) or in combination with levodopa.
It is also sometimes used off label as a treatment for cluster headache and to counteract the problems with sexual dysfunction experienced by some users of the selective serotonin reuptake inhibitor (SSRI) antidepressants. Pramipexole has shown robust effects on pilot studies in a placebo-controlled proof of concept study in bipolar disorder. It is also being investigated for the treatment of clinical depression and fibromyalgia.
| АРТИКУЛИ |
STANDARDS
|
РЕЗУЛТАТИ
|
Външен вид
|
White or off-white crystalline powder |
Off-white crystalline powder |
| Идентификация |
Чрез IR |
Съответства |
| RT under chirality should complies |
Съответства |
| Хлорид: it gives a reaction of chloride |
Съответства |
| вода |
3.0%~4.5% |
3.4% |
Точка на топене
|
198.0~202.0ºC |
199.8~200.5ºC |
| Остатък при запалване |
≤0,2% |
0.08% |
| Тежки метали |
≤10ppm |
Съответства |
| Сродни вещества |
Individual Impurities:≤0,5% |
0.15% |
| Общо примеси:≤1,0% |
0.22% |
| E.E |
≥99,0% |
99.6% |
Анализ (on dry basis)
|
98.0%~102,0% |
101.2% |
| Заключение:It complies to prescribed enterprise standard. |