Albuterol sulfate Salbutamol sulfate 51022-70-9
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Salbutamol or albuterol s a short-acting β2-adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease. It is marketed as Ventolin among other brand names.
Salbutamol was the first selective β2-receptor agonist to be marketed — in 1968. It was first sold by Allen & Hanburys under the brand name Ventolin. The drug was an instant success, and has been used for the treatment of asthma ever since.
Albuterol Sulfate/Salbutamol/Ventolin powders/Proventil powders/CAS No: 51022-70-9
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 or almost white,crystalline powder |
Conform |
|
Solubility |
Freely soluble in water,practically insoluble or very slightly soluble in alcohol and in methylene chloride. |
Conform |
|
Identification |
A |
The UV absorption spectrum of the sample shows an absorption maximum at 276nm.The specific absorbance at the Maximum is55 to 64. |
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 |
|
E |
It geves reaction (a) of sulphates. |
Conform |
|
Appearance of solution |
Solution S is clear and not more intensely coloured than reference solution in BY6. |
Conform |
|
Optical rotation |
negative 0.10° to +0.10°determined on solution S. |
+0.01° |
|
Acidity or alkalinity |
NMT 0.4ml of 0.01M HCL is required to change the color of the indicator to red. |
Conform |
|
Related substances |
Impurity J ≤0.20% |
Conform |
|
Any other impurity ≤0.30% |
Conform |
||
Total impurity ≤1.0% |
Conform |
||
Boron |
≤50ppm |
Conform |
|
Sulphated ash |
≤0.10% |
0.06% |
|
Loss on drying |
≤0.5% |
0.30% |
|
Assay(on dried basis) |
98.0~101.0% |
99.5% |
|
Conclusion |
The test results above BP2009 |
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