Garsorasib API | KRAS G12C Inhibitor Pharmaceutical API

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Garsorasib API

Garsorasib is a synthetic small-molecule KRAS G12C inhibitor developed for the treatment of cancers carrying the KRAS G12C mutation. It is also known by the development code D-1553. Garsorasib selectively targets the mutant KRAS G12C protein and inhibits KRAS-dependent signaling pathways involved in tumor-cell proliferation and survival.

Garsorasib API Manufacturer in India

Garsorasib is a specialized oncology pharmaceutical active ingredient belonging to the KRAS inhibitor class. It is a chemically synthesized small molecule requiring controlled manufacturing, purification and analytical characterization.

Chemical Information

CAS Number: 2559761-14-5
Molecular Formula: C32H32F2N8O2
Molecular Weight: 598.65 g/mol
Development Code: D-1553
Molecule Type: Small Molecule
Drug Class: KRAS Inhibitor
Target: KRAS G12C
Therapeutic Area: Oncology

Mechanism of Action

Garsorasib selectively binds to the mutant KRAS G12C protein and inhibits KRAS G12C-dependent signaling. KRAS is involved in intracellular signaling pathways that regulate cell growth, proliferation and survival. Inhibition of the mutant KRAS G12C pathway can suppress abnormal tumor-cell signaling.

Pharmaceutical Applications

Garsorasib has been developed for the treatment of KRAS G12C-mutated solid tumors, particularly advanced non-small-cell lung cancer (NSCLC). It has also been investigated in other KRAS G12C-mutated cancers, including colorectal cancer.

Garsorasib in Oncology

KRAS G12C is a specific oncogenic mutation found in several cancers. Garsorasib was designed to selectively inhibit this mutated form of KRAS rather than broadly inhibiting normal cellular signaling.

Physical and Chemical Properties

Garsorasib is a synthetic small molecule with the molecular formula C32H32F2N8O2 and molecular weight 598.65 g/mol. It has two defined stereocenters and is electrically neutral.

Quality and Analytical Testing

Garsorasib API quality evaluation may include identity by IR/HPLC/LC-MS, assay by HPLC, related substances, residual solvents, water content, residue on ignition, elemental impurities and other applicable pharmaceutical quality-control tests.

Storage

Garsorasib should be stored in a tightly closed container under controlled pharmaceutical storage conditions and protected from excessive heat, moisture and direct light. Final storage requirements should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Garsorasib has been evaluated as an orally available KRAS G12C inhibitor in clinical studies involving KRAS G12C-mutated cancers. Its development code is D-1553, and its chemical identity is documented by FDA GSRS and PubChem.

Garsorasib API Summary

Garsorasib is a synthetic KRAS G12C inhibitor with CAS Number 2559761-14-5, molecular formula C32H32F2N8O2, and molecular weight 598.65 g/mol. It is also known as D-1553 and is an oncology-focused small-molecule API.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Water Content NMT 1.0%
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