| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| 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 me'thylene 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 me'thylene 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 |
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It is usually given by the inhaled route for direct effect .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 maxi'mal effect of salbutamo 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.
For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient.
Each actuation of PROVENTIL® HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four "test sprays" into the air, away from the face.
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