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Albuterol sulfate/Ventolin/Proventil

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White or near white crystalline powder
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  • Description
  • Reviews(87)

Albuterol sulfate
Alias: Salbutamol HCL; Ventolin;  Proventil
CAS No: 51022-70-9,18559-94-9
EINECS No: 242-424-0
MF: C13H21NO3
MW: 239.31
Melting point: 155- 180 °C

Purity: 99.5%
Appearance: White or near white crystalline powder.Melting point of 157-158 ℃, soluble in ethanol, soluble in water, slightly soluble in ether.Odorless, bitter taste .

Usage: Used in the treatment of bronchial asthma, asthmatic bronchitis, emphysema, patients bronchospasm.

Applications:  
It is usually given by the inhaled route for direct effect on bronchial smooth muscle. This is usually achieved through a metered dose inhaler (MDI), nebulizer or other proprietary delivery devices (e.g. Rotahaler or Autohaler). In these forms of delivery, the maximal effect of salbutamol can take place within five to 20 minutes of dosing, though some relief is immediately seen. It can also be given intravenously.

Used in the treatment of bronchial asthma, asthmatic bronchitis, emphysema, patients bronchospasm.

Specifications:   COA

Test Items

Specification

Test Results

Appearance

white oralmost white,crystalline powder

Conform

Solubility

Sparingly soluble in water,soluble in ethanol(96 per cent).

Conform

Melting point

About 155℃

155.5℃

Identification

A

Examined between 230 nm and 350 nm(2.2.25) ,the solution shows an absorption  maximum at 276nm.The specific absorbance at the absorption Maximum is 66 to 75.

Conform

 

B

Infraed absorption spectrophotometry.

Conform

 

C

Chromatogram obtained with test solution (b) is similar in position color & size to the principal spot in the chromatogram obtained with the reference solution.

Conform

 

D

An orange-red color develop in methylene chloride layer.

Conform

Appearance of solution

Solution S is clear(2.2.1) and not more intensely coloured than reference solution in BY5.

Conform

Optical rotation

﹣0.10° to +0.10°determined on solution S.

+0.02°

Related substances

Impurity J ≤0.20%

Conform

 

Impurity D ≤0.30%

Conform

 

Impurity F ≤0.30%

Conform

 

Impurity G ≤0.30%

Conform

 

Each impurity A,B,C,E,H,I ≤0.30%

Conform

 

Total impurity ≤1.0%

Conform

Boron

≤50ppm

Conform

Sulphated ash

≤0.10%

0.03%

Loss on drying

≤0.5%

0.25%

Assay(on dried basis)

98.0~101.0%(dried substance)

99.6%

Conclusion

The test results above BP2009



Average rating: 5.0 based on 87 reviews
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