Alias: Salbutamol HCL; Ventolin; Proventil
CAS No: 51022-70-9,18559-94-9
EINECS No: 242-424-0
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.
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.
|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|
|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|