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 |
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Items Specifications Product Name Salbutamol Other Name alpha-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-alpha,alpha-diol; Albuterol CAS No. 18559-94-9 EINECS 242-424-0 Molecular Formula C13H21NO3 Molecular Weight 239.31 Appearance Its sulfate is white or nearly white ...
Whatsapp: +8618132200205 Wickr:Rachel2028 Email:rachel@sdwenhou.com Name: Salbutamol CAS NO: 18559-94-9 EINECS:242-424-0 ...