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Levothyroxine sodium

Certification of Analysis

 

Product Name

Levothyroxine sodium

Catalog No

SC-13972

CAS Number

55-03-8

Quantity    

25kg

Batch No

20110301

Product Date 

2011.03.01

Date of analysis  

2011.03.01

 

 

 

 

 

 

 

 

 

Items of analysis

Specification

Results

Appearance

White or pale-yellow crystalline powder

Conforms

Specific rotation

+18°~+20°

(C=1,ethanol:1N NaOH = 2:1)

+18.4°

Melting point

226230

227230

Loss on drying

 ≤0.20%

0.15%

Residue on ignition

0.1%

0.07%

Heavy metals(Pb)

10ppm

10ppm

Assay(HPLC)

98.0%

98.6%

Conclusion

It accords with the Enterprise Standard

 

 

Analyst: Carlos Lin                                              Check: Sally Chen                                                           Date: 2011-03-01