Certification of Analysis
Product Name |
Levothyroxine sodium |
Catalog No |
SC-13972 |
CAS Number |
|
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:
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