General Information

Sotorasib Impurities and Sotorasib 

Daicel Pharma synthesizes high-quality Sotorasib impurities like Sotorasib Isomer-3 and Sotorasib Isomer-4, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Sotorasib. Moreover, Daicel Pharma offers custom synthesis of Sotorasib impurities and delivers them globally.

Sotorasib [CAS: 2296729-00-3] is a pyridopyrimidine derivative that treats non-small cell lung cancer (NSCLC) in patients having KRAS(G12C) mutations. It inhibits growth in KRAS G12C tumor cell lines.

Sotorasib: Use and Commercial Availability  

Sotorasib, or AMG 510, is a drug taken orally with the potential to treat certain types of cancer. It treats non-small cell lung cancer (NSCLC) in adults with advanced cancer and has a KRAS G12C mutation. It is available under the trade name Lumykras. Lumykras is a medicine for treating advanced NSCLC with KRAS G12C mutation in adults who have progressed after at least one prior line of systemic therapy. Amgen is the company that developed this drug.

Sotorasib Structure and Mechanism of Action

The chemical name of Sotorasib is (1R)-6-Fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-[4-methyl-2-(1-methylethyl)-3-pyridinyl]-4-[(2S)-2-methyl-4-(1-oxo-2-propen-1-yl)-1-piperazinyl]pyrido[2,3-d]pyrimidin-2(1H)-one. Its chemical formula is C₃₀H₃₀F₂N₆O₃, and its molecular weight is approximately 560.6 g/mol.

Sotorasib inhibits KRAS^G12C, a mutant-oncogenic, tumor-restricted form of the RAS GTPase, KRAS. It covalently binds with the cysteine of KRAS^G12C  blocks KRAS signaling, slows cell growth, and allows apoptosis only in KRAS G12C tumor cell lines.

Sotorasib Impurities and Synthesis

Sotorasib is a promising targeted therapy for non-small cell lung cancer with a specific mutation, but it may produce impurities during synthesis¹. These impurities may affect the drug’s purity, stability, and efficacy. Therefore, it is crucial to identify the potential impurities, understand their formation, and develop strategies to control and monitor them to ensure the drug’s quality and safety.

Daicel provides a Certificate of Analysis (CoA) for Sotorasib impurity standards, Sotorasib Isomer-3, and Sotorasib Isomer-4. The CoA is issued from a cGMP-compliant analytical facility and contains complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². Additional characterization data, such as 13C-DEPT and CHN, can be provided upon request. Daicel can also prepare any unknown Sotorasib impurity or degradation product. We give a complete characterization report on delivery.