Acebutolol
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Certification of Analysis
Product Name
Acebutolol
CAS No
37517-30-9
Catalog No
SC-47252
Quantity
500kg
Batch No
20121231
Product Date
2012.12.31
Date of analysis
2012.12.31
Items of analysis
Specification
Results
Appearance
White or almost white, crystalline powder
White crystalline powder
Solubility
Freely soluble in water and in ethanol (96 percent), very slightly soluble in acetone and in methylene chloride.
Conforms
MP
About 143℃
143.8℃
Identification IR
Infrared absorption spectrophotometry (2.2.24). Preparation Discs. Comparisonacebutolol hydrochloride CRS.
Conforms
Identification chlorides
It gives reaction (a) of chlorides.
Conforms
PH
5.0-7.0
5.5
Loss on drying
≤0.5%
0.04%
Sulfated Ash
≤0.1%
0.05%
Heavy metals
≤10ppm
Conforms
Related Substances
Impurity B
≤0.2%
0.00%
Impurity C
≤0.1%
0.04%
Impurity I
≤0.2%
0.00%
Maximum Single Impurity
≤0.1%
0.06%
Total impurities
≤0.5%
0.18%
Assay(dried basis)
99.0%~101.0%
99.9%
Remark
Declaration: For laboratory use by technically qualified individual only
Conclusion
It accords with the Enterprise Standard
Analyst: Jack Fu Check: Anne Zhang Date: 2012-12-31
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