191732-72-6 Lenalidomide Revlimi
Lenalidomide
Product name: Lenalidomide
Synonyms: lenalidomide;3-(7-amino-3-oxo-1h-isoindol-2-yl)piperidine-2,6-dione;LenalidomideLenalidomide; 1-Oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline;3-(4-Amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6-piperidinedione;CC-5013;Revlimi;Lenalidomide(other anti-cancers)
Molecular Formula: C13H13N3O3
Formula Weight: 259.26062
CAS No.: 191732-72-6
Product Name |
Lenalidomide |
CAS No. |
191732-72-6 |
Manufacture Date |
2014-2-18 |
Analysis Date |
2014-2-18 |
Batch No. |
20140218 |
Expiry Date |
2016-2-17 |
Item |
Specifications |
Results |
|
Appearance |
White to light yellow crystalline powder |
Conform |
|
Solubility |
Solubility slightly soluble in methanol and acetonitrile |
Conform |
|
Identification |
IR, HPLC |
Conform |
|
Specific rotation |
-2- +2°C |
0°C |
|
Water content |
≤4.0% |
2.67% |
|
Residue on ignition |
≤0.5% |
0.2% |
|
Heavy metal |
≤20ppm |
Conform |
|
Residual Solvents |
Methaol≤3000ppm |
1000ppm |
|
Acetonitrile≤410ppm |
N D |
||
Carbon tetrachloride≤4ppm |
N D |
||
Tetrahydrofuran≤720ppm |
210ppm |
||
Dimethylformamide≤550ppm |
290ppm |
||
Related Substance |
Single Impurity≤1.0% |
0.6% |
|
Total Impurity≤2.0% |
0.9% |
||
Assay |
≥99% |
99.4 % |
|
Microbiological Limit |
Total aerobic bacteria NMT NMT 103 per 1g of API Total fungus NMT NMT 102 per 1g of API Absence of Escherichia coli per 1g of API |
Conform |
|
Conclusion: It complies with the standard |
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