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Active Pharmaceuticals

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Product Name: Pramipexole Hydrochloride
Synonyms: PRAMIPEXOLE DIHYDROCHLORIDE; PRAMIPEXOLE HCL; (s)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride; PramipexoleDihcl;
CAS: 104632-25-9
Grade: medical grade
Assay: 99%
Molecular Formula: C10H19Cl2N3S
Molecular Weight: 284.25
Melting point: 288-290°C
Appearance: white crystalline powder
Category: 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.

ITEMS

STANDARDS

RESULTS

Appearance

White or off-white crystalline powder Off-white crystalline powder
Identification By IR Complies
RT under chirality should complies Complies
Chloride: it gives a reaction of chloride Complies
Water          3.0%~4.5% 3.4%

Melting Point

198.0~202.0ºC 199.8~200.5ºC
Residue on Ignition ≤0.2% 0.08%
Heavy Metals ≤10ppm Complies
Related Substances Individual Impurities:≤0.5% 0.15%
Total Impurities:≤1.0% 0.22%
E.E ≥99.0% 99.6%

Assay (on dry basis)

98.0%~102.0% 101.2%
Conclusion:It complies to prescribed enterprise standard.

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