盐酸帕洛诺司琼（GMP)

Palonosetron Hydrochloride

CAS:
135729-62-3

Introduction:
Palonosetron is a 5-HT3 antagonist used in the prevention and treatment of chemotherapy -induced nausea and vomiting, Palonosetron is the only drug of its class approved for this use by the FDA .Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol.

Simcere's Palonosetron Hydrochloride API:
Simcere’s API and preparations of Palonosetron are both successfully passed and received SFDA GMP certification. Its brand name is Nuowei

Some inspection data
Specification            CP
Properties               White or off white crystalline powder
Specific Rotation        -97.0o
PH                        5.4
Loss on drying           0.5% max
Residue on ignition       0.1% max
Heavy metals             10 ppm max
Arsenic                  1 ppm max
Total bacteria           1000 cfu/g max
Yeasts and Moulds        100 cfu/g max
Escherichia coli         Not detected
Assay                    99.7 %

Keyword: Palonosetron, Palonosetron Hydrochloride, 135729-62-3

盐酸帕洛诺司琼

盐酸帕洛诺司琼

CAS号：
135729-62-3

产品介绍：
帕洛诺司琼是一个5-羟色胺拮抗剂,用于预防和治疗化疗引起的恶心和呕吐,它是同类产品中唯一一个被美国FDA批准上市的药品。帕洛诺司琼盐酸盐是一种白色或类白色结晶性粉末。它易溶于水，易溶于丙二醇，微溶于乙醇和2-丙醇。

先声药业的帕洛诺司琼原料药：
先声药业的帕洛诺司琼原料药和制剂成功通过了SFDA的GMP认证。制剂商品名为诺威。

一些产品参数
产品标准         CP
性    状         白色或类白色结晶性粉末
比 旋 度         -97.0o
酸    度         5.4
干燥失重         小于0.5%
炽灼残渣         小于0.1%
重 金 属          小于10 ppm
砷               小于1 ppm
细菌总数         小于1000 cfu/g
霉菌与酵母菌总数 小于100 cfu/g
大肠杆菌          不得检出
含    量         99.7 %

关键词:  帕洛诺司琼, 帕洛诺司琼盐酸盐, 盐酸帕洛诺司琼 135729-62-3

Simcere Bulk Pharmaceuticals Division
Address：No.699-18, Xuanwu Avenue Nanjing, P. R. China，210042
TEL:     +86 (25) 8556 6666-8851
        Fax:     +86 (25) 8528 1765
E-mail:  yuanliaoyao@simcere.com
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