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