Cilastatin Sodium
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Product Name
Cilastatin Sodium
CAS No
81129-83-1
Catalog No
SC-16116
Quantity
10g
Batch No
20151201
Product Date
2015.12.01
Date of analysis
2016.7.29

 
 
 
 
 
Items of analysis
Specification
Results
Appearance
A white or off-white powder
Off-white powder
Solubility
Soluble in water and methanol, insoluble in acetone
Conforms
Identification
IR
Specific ratation
Sodium
Conforms
Specific rotation
+41.5°～+44.5°
+43.2°
pH
6.5～7.5
7.0
Heavy metal
≤20ppm
Conforms
Assay(on dry basis)
98.0%～101.5%
99.1%
Related compounds
Maximum Individual impurity
≤0.5%
0.1%
Total impurities
≤1.5%
1.0%
Residual solvents
Acetone
≤5000ppm
630ppm
Methanol
≤5000ppm
Not detected
Mesityl oxide
≤4000ppm
Not detected
Remark
Declaration: For laboratory use by technically qualified individual only
Conclusion
It accords with the Enterprise Standard
Effective date period:one year

Analyst: Jack Fu                            Check: Anne Zhang                             Date: 2016-07-29

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