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Product Picture
型號:
品名:Biosoprolol Fumarate
產品說明:
分子式 : (C18H31NO4)•1/2C4H4O4
分子量 :766.98
化學名 :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.

藥理 :

本品為β-1選擇性腎上腺素接受體阻斷劑。
適應症 :高血壓、狹心症。

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%



 

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