Garsorasib API Manufacturer in India

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Garsorasib API Manufacturer and Bulk Supplier in India

Garsorasib API (CAS No: 2559761-14-5)

Selective KRAS G12C Inhibitor API for Targeted Oncology and Non-Small Cell Lung Cancer Pharmaceutical Development

Garsorasib API (CAS No. 2559761-14-5) is a synthetic small-molecule targeted oncology active pharmaceutical ingredient associated with KRAS G12C-mutated cancer pharmaceutical development.

Garsorasib, also known by the development code D-1553, is an orally active and selective inhibitor of the oncogenic KRAS G12C mutant protein.

KRAS is a small GTPase involved in intracellular signaling pathways that regulate cell growth, proliferation, and survival. The KRAS G12C mutation substitutes glycine with cysteine at amino acid position 12 and may contribute to persistent oncogenic signaling in susceptible tumor cells.

Garsorasib covalently binds to the cysteine residue of GDP-bound KRAS G12C and stabilizes the mutant protein in an inactive state. This inhibits KRAS-dependent downstream signaling pathways associated with tumor-cell proliferation and survival.

Pharmaceutical companies sourcing Garsorasib API commonly evaluate assay, HPLC purity, stereochemical identity, chiral purity, related substances, process-related impurities, degradation products, residual solvents, water content, crystalline form, particle size distribution, and batch-to-batch consistency.

Because Garsorasib is a covalent targeted inhibitor with defined stereochemical characteristics, control of enantiomeric impurities, electrophilic warhead-related degradation, process impurities, and solid-state properties is important during API qualification.

Particle size distribution and crystalline characteristics may also influence dissolution, formulation processing, and oral solid dosage-form development.

Swapnroop Drugs and Pharmaceuticals supplies Garsorasib API for qualified pharmaceutical research, targeted oncology drug development, analytical, formulation development, and regulated manufacturing requirements with product-specific quality documentation, pharmaceutical-grade packaging, and reliable supply-chain coordination.

 

 

Critical Quality Requirements for Garsorasib API

Pharmaceutical companies evaluating Garsorasib API commonly focus on:

  • HPLC assay and chromatographic purity
  • Chemical identity
  • Molecular mass confirmation
  • Stereochemical identity
  • Chiral purity
  • Enantiomeric impurity control
  • Related substances
  • Process-related impurity control
  • Degradation product monitoring
  • Electrophilic functionality-related degradation
  • Residual solvent profile
  • Water and moisture content
  • Elemental impurity assessment
  • Crystal-form consistency
  • Particle size distribution
  • Powder handling characteristics
  • Batch-to-batch consistency
  • Stability under recommended storage conditions

Stereochemical consistency is an important quality consideration for Garsorasib API because the molecular structure contains defined stereochemical configurations.

Control of the covalent-binding electrophilic functionality and related degradation products may also be evaluated during API development and stability studies.

Key Features

  • Garsorasib API CAS No. 2559761-14-5
  • Also known as D-1553 or D1553
  • Synthetic targeted oncology active pharmaceutical ingredient
  • Selective KRAS G12C inhibitor
  • Covalent small-molecule inhibitor
  • Orally active targeted oncology compound
  • Molecular formula C32H32F2N8O2
  • Molecular weight approximately 598.6 g/mol
  • Selective targeting of mutant KRAS G12C
  • Controlled HPLC purity profile
  • Chiral purity monitoring
  • Enantiomeric impurity control
  • Related substances monitored according to approved specification
  • Process and degradation impurity monitoring
  • Crystal-form consistency evaluation
  • Particle size requirements coordinated as applicable
  • Residual solvents controlled according to applicable ICH Q3C requirements
  • Elemental impurities evaluated according to applicable ICH Q3D requirements
  • Pharmaceutical-grade packaging
  • COA and MSDS available as applicable
  • Bulk pharmaceutical supply and export coordination

Applications of Garsorasib API

Garsorasib API is primarily associated with:

  • KRAS G12C targeted oncology drug development
  • Non-small cell lung cancer pharmaceutical development
  • KRAS G12C-mutated NSCLC research
  • Targeted anticancer pharmaceutical development
  • KRAS inhibitor formulation development
  • Covalent inhibitor pharmaceutical research
  • Precision oncology research
  • Solid tumor drug development
  • Colorectal cancer targeted therapy research
  • Oral oncology formulation development
  • Analytical method development
  • Oncology API research
  • Pharmaceutical formulation development
  • Approved pharmaceutical manufacturing requirements

Garsorasib-related pharmaceutical products are associated with targeted treatment strategies for tumors harboring the KRAS G12C mutation.

Garsorasib API for KRAS G12C Targeted Pharmaceutical Development

Garsorasib is designed to selectively inhibit the oncogenic KRAS G12C mutant protein.

Pharmaceutical companies evaluating Garsorasib API may review:

  • API assay
  • HPLC purity
  • Chemical identity
  • Molecular mass
  • Stereochemical identity
  • Chiral purity
  • Enantiomeric impurities
  • Related substance profile
  • Process-related impurities
  • Degradation products
  • Residual solvents
  • Moisture content
  • Crystal form
  • Particle size distribution
  • Formulation compatibility
  • Stability data
  • Batch-to-batch consistency

Product-specific API specifications should be evaluated according to the intended dosage form, formulation process, target regulatory market, and approved pharmaceutical development requirements.

Garsorasib Mechanism of KRAS G12C Inhibition

KRAS cycles between active GTP-bound and inactive GDP-bound conformational states.

The KRAS G12C mutation introduces a cysteine residue at amino acid position 12.

Garsorasib selectively binds covalently to GDP-bound KRAS G12C and stabilizes the mutant protein in its inactive state.

This reduces KRAS G12C-mediated downstream oncogenic signaling associated with tumor-cell proliferation, survival, invasion, and disease progression.

The selective covalent targeting strategy is designed to inhibit mutant KRAS G12C while minimizing direct binding to wild-type KRAS.

Garsorasib API for Targeted Oncology Formulations

Garsorasib is associated with oral targeted oncology pharmaceutical development.

Formulation-development considerations may include:

  • API particle size
  • Crystal form
  • Solid-state stability
  • Dissolution characteristics
  • Drug-excipient compatibility
  • Moisture sensitivity
  • Oxidative stability
  • Tablet manufacturing characteristics
  • Content uniformity
  • Stability under intended packaging conditions

Particle-size-controlled or solid-state-specific API requirements should be confirmed according to the intended formulation and approved product specification.

Garsorasib and D-1553

Garsorasib and D-1553 refer to the same active pharmaceutical compound.

D-1553 was used as the development code during clinical development.

Garsorasib is the recognized drug name for the KRAS G12C inhibitor.

Procurement, formulation, quality, and regulatory teams should use CAS No. 2559761-14-5 to confirm the exact Garsorasib chemical identity.

Why Choose Swapnroop for Garsorasib API?

Swapnroop Drugs and Pharmaceuticals supports qualified pharmaceutical and oncology-development customers with:

  • Reliable Garsorasib API supply coordination
  • Product-specific specification support
  • COA and MSDS availability as applicable
  • Technical documentation coordination
  • Chiral purity requirement coordination
  • Related substance specification support
  • Secure pharmaceutical-grade packaging
  • Development and commercial quantity supply coordination
  • Particle size requirement coordination as applicable
  • Export documentation assistance
  • Global pharmaceutical supply coordination
  • Dedicated commercial enquiry support
  • Support for targeted oncology pharmaceutical development requirements

Packaging & Supply

Garsorasib API is supplied in secure pharmaceutical-grade packaging selected according to product quantity, stability requirements, moisture protection requirements, and customer specifications.

Product-appropriate inner packaging and approved pharmaceutical-grade outer containers may be used according to the supplied material specification.

Available packaging configurations may include:

  • Development and analytical quantities
  • 100 g packaging
  • 500 g packaging
  • 1 kg packaging
  • 5 kg packaging
  • Commercial quantities as applicable
  • Customer-specific packaging according to requirement

Packaging configuration, MOQ, commercial quantity, particle size requirements, and shipment conditions are confirmed according to the approved product specification and customer enquiry.

Storage and Handling

Store Garsorasib API in tightly closed and appropriately labeled containers under the controlled storage conditions specified in the approved product documentation.

Protect the material from excessive moisture, heat, direct light, oxidation, and unsuitable environmental exposure.

Handling should be performed by trained personnel using approved pharmaceutical and potent compound handling procedures, appropriate containment practices, and applicable safety documentation.

Product-specific storage and handling requirements should be confirmed from the approved COA, SDS, specification, and stability documentation.

Garsorasib API Manufacturer and Supplier in India

Swapnroop Drugs and Pharmaceuticals provides Garsorasib API bulk supply and export support in India for qualified pharmaceutical manufacturers, targeted oncology drug developers, analytical laboratories, formulation-development organizations, research companies, and pharmaceutical procurement customers.

For Garsorasib API price, CAS No. 2559761-14-5, HPLC purity, chiral purity, related substance profile, COA availability, MOQ, particle size, packaging, and export enquiries, contact our pharmaceutical sales team.

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