ENGLISH 繁体中文 网站导览 回前页
:: 原料药
Product Picture
型号:
品名:Biosoprolol Fumarate
产品说明:
分子式 : (C18H31NO4)·1/2C4H4O4
分子量 :766.98
化学名 :2-Propanol,1-[4-[[2-(1-methylethoxy)ethoxy]methyl]
phenoxy]-3-[(1-methylethyl)-amino]-,(±)-,(E)-2-butenedioate (2:1) (salt)

活性成份 :

Bisoprolol Fumarate contains the equivalent of not less than 831μg of bisoprolol(C18H31NO4) per mg,calculated on the anhydrous basis.

药理 :

本品为β-1选择性肾上腺素接受体阻断剂。
适应症 :高血压、狭心症。

Item

Specification

Result

Appearance

White crystalline powder

White crystalline powder

Identification :

 

 

a. IR

Conform to the reference standard spectrum

Conforms

b. HPLC

The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the Assay

Conforms

Specific rotation

-2° ~ +2°

0.09862

Water (Karl Fischer)

No more than 0.5 %

0.280%

Residue on ignition

No more than 0.1 %

0.020%

Heavy metals

No more than 0.002 %

Pass

Related substances

No more than 0.5 %

0.238%

Content of fumaric acid

Between 14.8 % and 15.4 %

15.30%

Residual solvent

 

 

Toluene

No more than 890 ppm

Undetected

Isopropyl alcohol

No more than 5000 ppm

Undetected

Acetone

No more than 5000 ppm

Undetected

2-isopropoxyethanol

No more than 100 ppm

Undetected

Assay

97.5-102.0%

99.50%



 

|
桃园市桃园区介寿路22号 TEL: 886-3-361-2131 FAX: 886-3-367-0029 E-mail: service@sintong.com Copyright© 2019 信东生技股份有限公司