Lenalidomide

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3-(4-nitroso-1-oxoisoindolin-2-yl)piperidine-2,6-dione

  • CAT NUMBER DCTI-C-2930
  • CAS NUMBER NA
  • MOLECULAR FORMULA C13H11N3O4
  • MOLECULAR WEIGHT 273.25

4-Nitro Lenalidomide

  • CAT NUMBER DCTI-C-2942
  • CAS NUMBER 827026-45-9
  • MOLECULAR FORMULA C13H11N3O5
  • MOLECULAR WEIGHT 289.25

4-Nitrophthalide (Lenalidomide KSM lactone impurity)

  • CAT Number DCTI-C-060
  • CAS Number 65399-18-0
  • Molecular Formula C8H5NO4
  • Molecular Weight 179.13

Lenalidomide Amadori Impurity

  • CAT Number DCTI-C-1314
  • CAS Number 219843-78-4
  • Molecular Formula C25H33N3O13
  • Molecular Weight 583.55

Lenalidomide Impurity 19

  • CAT NUMBER DCTI-C-2975
  • CAS NUMBER 1063995-41-4
  • MOLECULAR FORMULA C17H22N2O5
  • MOLECULAR WEIGHT 334.37

Lenalidomide Impurity-3

  • CAT Number DCTI-C-383
  • CAS Number 295357-66-3
  • Molecular Formula C13H14N2O5
  • Molecular Weight 278.26

Lenalidomide open chain Amadori impurity

  • CAT Number DCTI-C-1383
  • CAS Number NA
  • Molecular Formula C25H33N3O13
  • Molecular Weight 583.55

Methyl 2-(bromomethyl)-4-nitrobenzoate

  • CAT Number DCTI-C-179
  • CAS Number 133446-99-8
  • Molecular Formula C9H8BrNO4
  • Molecular Weight 274.07

Methyl 2-(bromomethyl)-5-nitrobenzoate

  • CAT Number DCTI-C-180
  • CAS Number 90725-68-1
  • Molecular Formula C9H8BrNO4
  • Molecular Weight 274.07
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General Information

Lenalidomide Impurities and Lenalidomide

Daicel Pharma offers worldwide delivery options for custom synthesis of Lenalidomide impurity standards, including crucial impurity standards such as 4-Nitrophthalide (Lenalidomide KSM lactone impurity), Lenalidomide Amadori impurity, Lenalidomide Impurity-3, Lenalidomide open-chain Amadori impurity, Methyl 2-(bromomethyl)-4-nitrobenzoate, Methyl 2-(bromomethyl)-5-nitrobenzoate, Methyl 2-(bromomethyl)-6-nitrobenzoate, and Methyl 2-(chloromethyl)-3-nitrobenzoate. These impurity standards play a vital role in evaluating the purity and safety of Lenalidomide, an active pharmaceutical ingredient.

Lenalidomide [CAS: 191732-72-6] is an analog of thalidomide with anti-cancer properties. It is an immunomodulator and anti-neoplastic agent treating multiple myeloma. Derived from phthalimide and piperidone, Lenalidomide exhibits immunomodulatory and anti-angiogenic characteristics. It manages transfusion-dependent anemia in myelodysplastic syndromes and relapsed or refractory mantle cell lymphoma.

Lenalidomide: Use and Commercial Availability

Lenalidomide, available as Revlimid, is a US FDA-approved analog of thalidomide used for treating various conditions. It manages myelodysplastic syndrome (MDS) in patients with transfusion-dependent anemia or genetic abnormality. Lenalidomide is also for refractory or relapsed multiple myeloma, either as monotherapy or in combination with dexamethasone, bortezomib, and dexamethasone, or melphalan and prednisone for newly diagnosed patients who are ineligible for transplant. Additionally, it treats relapsed or refractory mantle cell lymphoma.

Lenalidomide Structure and Mechanism of Action Lenalidomide Structure and Mechanism of Action 

The chemical name of Lenalidomide is 3-(4-Amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6-piperidinedione. Its chemical formula is C13H13N3O3, and its molecular weight is approximately 259.26 g/mol.

Lenalidomide prevents the secretion of pro-inflammatory cytokines and raises the secretion of anti-inflammatory cytokines.

Lenalidomide Impurities and Synthesis 

During the manufacturing1 of Lenalidomide, impurities can form as byproducts. They can affect the quality and safety of the drug. Various analytical techniques, such as high-performance liquid chromatography (HPLC), helps identify and quantify these impurities. Strict control measures ensure the impurity levels remain within acceptable limits. The impurity profile of Lenalidomide is closely monitored throughout the manufacturing process to maintain its purity and potency.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Lenalidomide impurity standards. We provide a range of Lenalidomide impurity standards, such as 4-Nitrophthalide (Lenalidomide KSM lactone impurity), Lenalidomide Amadori impurity, Lenalidomide Impurity-3, Lenalidomide open-chain Amadori impurity, Methyl 2-(bromomethyl)-4-nitrobenzoate, Methyl 2-(bromomethyl)-5-nitrobenzoate, Methyl 2-(bromomethyl)-6-nitrobenzoate, and Methyl 2-(chloromethyl)-3-nitrobenzoate. Our impurities have a detailed Certificate of Analysis (CoA) and a comprehensive characterization report. The CoA encompasses data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis2. Additional data, such as 13C-DEPT, can be provided upon request. We can synthesize unknown Lenalidomide impurity standards or degradation products. Each delivery has a comprehensive characterization report.

References
FAQ's

Frequently Asked Questions

Analytical techniques such as high-performance liquid chromatography (HPLC), liquid chromatography (LC), or mass spectrometry (MS) help detect and quantify Lenalidomide impurities.

Stringent quality control measures are implemented during the manufacturing process of Lenalidomide to minimize impurities. It includes monitoring and optimizing reaction conditions, purification steps, and storage conditions.

Yes, impurities in Lenalidomide can contribute to the degradation and reduce its stability over time, potentially impacting its shelf life and therapeutic effectiveness.

The recommendation is to store Lenalidomide impurities at a controlled room temperature, within 2-8 °C.

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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