Levothyroxine sodium
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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
226～230℃
227～230℃
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
 
 

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