High quality Albuterol sulfate

Name

Albuterol sulfate

Synonyms

2-tert-Butylamino-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol hemisulfate; Salbutamol sulfate

Brand

Salus

Molecular Formula

2(C13H21NO3).H2O4S

Molecular Weight

576.70

CAS Registry Number

51022-70-9

EINECS

256-916-8

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

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