Salbutamol Sulphate Salbutamol Sulphate supplier high purity Salbutamol Sulphate
Test items |
Specification |
Results |
[Description] |
White or almost white,crystalline powder |
white,crystalline powder |
Specific rotation |
-0.10º~+0.10º |
0.00 º |
Solubility |
Freely soluble in water,practically insoluble or very slightly soluble in ethanol(96%) and in methylene chloride. |
Comply |
Identification |
A. The maximum absorption is at 276nm |
A.The maximum absorption is at 276.20nm |
|
C. The principal spot in the chromatogram obtained with the test solution is similar in position,colour and size to the principal spot in the chromatogram obtained with the reference solution. |
Comply |
|
D. An orange-red colour develops in the methylene chloride layer. |
Comply |
|
E. Positive reaction of Sulphate |
Comply |
Apearance of solution |
Clear and colouness |
Comply |
Boron |
≤50ppm |
Comply |
Sulfated ash |
≤0.1% |
0.04% |
Loss on drying |
≤0.5% |
0.2% |
Related substance |
Impurity D≤0.3% |
0.1% |
|
Impurity F≤0.3% |
ND |
|
Impurity C≤0.2% |
ND |
|
Impurity N≤0.2% |
ND |
|
Impurity O≤0.2% |
ND |
|
Unspecified Impurities≤0.1% |
0.05% |
|
Total Impurities≤0.9% |
0.05% |
Microbial count |
|
|
Bacterial count |
1000cfu/1g |
≤10cfu/1g |
Molds and yeast count |
≤100cfu/1g |
≤10cfu/1g |
Microbial limits |
Should comply |
Comply |
E.coli |
Shouldn’t found |
Not found |
[Assay] |
98.0%-101.0% |
99.6% |
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