63659-18-7 Betaxolol Betaxolol
Items |
Specifications |
Results |
Appearance |
White powder |
White powder |
Identification (by IR) |
Conforms to the GRS spectrum |
+91.4° |
Loss on drying |
≤0.5% |
0.2% |
Sulphated ash |
≤0.1% |
0.09% |
Assay(by HPLC) |
97.0%~103.0% |
99.7% |
Related substances (by HPLC) |
Any individual impurity ≤1.5% |
0.28% |
Total impurities≤ 2.0% |
0.62% |
|
Residual solvents |
Ethanol≤5000ppm Methylene chloride ≤600ppm Hexane ≤290ppm Dioxane ≤380ppm Pyridine ≤200ppm |
69ppm 43ppm Undetected (LOD 3ppm) Undetected(LOD 8pppm) Undetected (LOD 4ppm) |
Conclusion: meet the specification according to USP31. |
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