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Quick Detail:
Salbutamol (INN) or albuterol (USAN) is a short-acting β2-adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease.
Description:
Albuterol Sulfate
Alias: Salbutamol; Ventolin; Proventil
CAS No: 51022-70-9
EINECS No: 242-424-0
MF: (C13H21NO3)2·H2SO4
MW: 576.71
Purity: 99.5%
Appearance: White powder, soluble in the water and ethanol .
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
Test Items | Specification | Test Results | |
Appearance | white oralmost 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 | ﹣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% | 98.8% | |
Conclusion | The test results above BP2009 | ||
