Category
Lenalidomide
CAS Number
2197414-57-4
Molecular Formula
C13H15N3O4
Molecular Weight
277.3 g/mol
Synonym

5-Amino-4-(4-amino-1-oxoisoindolin-2-yl)-5-oxopentanoic acid ; 4-(4-Amino-1-oxoisoindolin-2-yl)-4-carbamoyl Butyric Acid;Lenalidomide - Impurity D;

Keywords
Amines
Heterocycles
Pharmaceutical Standards
Fine Chemicals
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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Lenalidomide Impurity 1 is used as a reference standard in analytical and quality control studies to detect and quantify process-related impurities during the synthesis of lenalidomide. It also supports stability testing and regulatory compliance to ensure the purity, safety, and efficacy of the final pharmaceutical product.