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Albuterol Sulfate

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Valid until: 2031-12-26
Updated on: 2015-03-17 13:09
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 Product Name: Albuterol Sulfate

CAS No.: 51022-70-9

Assay: 98.0%~101.0%

Solubility: Freely soluble in water, practically insoluble or very slightly soluble in alcohol and in methylene chloride

M.F.: C26H42N2O6  H2SO4

M.W: 576.71

Appearance: Almost white to white crystalline powder

Solubility: Freely soluble in water, practically insoluble or very slightly soluble in alcohol and in methylene chloride

Identification:

A: The UV absorption spectrum of the sample shows an absorption maximum at 276nm.The specific absorbance at the maximum is from 55 to 64.

B: IR positive

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.

D: Orange-red color develop in methylene chloride layer.

E: It gives reaction of sulfates.

Appearance of Solution: Solution S is clear and not more intensely colored than reference solution in BY6.

Optical Rotation: -0.10° to +0.10° determined on solution S.

Acidity or alkalinity: NMT 0.4ml of 0.01M HCL is required to change the color of the indicator to red.

Related substances: Impurity J: NMT 0.20%

                Any other impurity: NMT 0.30%

                Total impurities: NMT 1.0%

Boron: NMT 50ppm

Sulfated Ash: NMT 0.10%

Loss on Drying: NMT 0.50%

Details:

Salbutamol (INN) or albuterol (USAN) 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.
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