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Albuterol sulfate/Ventolin/Proventil

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  • Description

 

Albuterol sulfate
Alias: Salbutamol HCL; Ventolin;  Proventil
CAS No: 51022-70-9,18559-94-9
EINECS No: 242-424-0 
MF: C13H21NO3
MW: 239.31

Purity: 99.5%
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.


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 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
Boron ≤50ppm Conform
Sulphated ash ≤0.10% 0.03%
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
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