Imlunestrant API | Oral SERD API Manufacturer in India

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Imlunestrant API

Imlunestrant is an investigational oral selective estrogen receptor degrader (SERD) developed for the treatment of estrogen receptor (ER)-positive breast cancer. It is designed to bind to the estrogen receptor and promote its degradation, thereby suppressing estrogen-receptor-mediated signaling.

Imlunestrant is being investigated particularly in ER-positive, HER2-negative breast cancer, including settings involving acquired endocrine resistance.

Imlunestrant API Manufacturer in India

Imlunestrant is a specialized synthetic pharmaceutical compound requiring controlled manufacturing, purification and analytical characterization. Quality evaluation may include identity, assay, related substances, residual solvents, water content, elemental impurities and solid-state characterization.

Chemical Information

CAS Number: 2361179-56-4
Molecular Formula: C35H37F2N5O5S
Molecular Weight: 677.77 g/mol
Drug Class: Selective Estrogen Receptor Degrader
Pharmacological Class: Oral SERD
Therapeutic Area: Oncology / Breast Cancer

Mechanism of Action

Imlunestrant binds to the estrogen receptor (ER) and promotes receptor degradation. This reduces the amount of functional estrogen receptor available for estrogen-dependent signaling.

By suppressing ER signaling, Imlunestrant is designed to inhibit proliferation of estrogen receptor-positive breast cancer cells.

Pharmaceutical Research Applications

Imlunestrant is being investigated in pharmaceutical research involving:

  • ER-positive breast cancer
  • HER2-negative breast cancer
  • Endocrine-resistant breast cancer
  • Estrogen receptor signaling
  • Selective estrogen receptor degradation
  • Targeted endocrine therapy

Oral SERD Development

Unlike traditional selective estrogen receptor modulators, oral SERDs are designed to both bind to the estrogen receptor and promote receptor degradation. Imlunestrant is being studied as an orally administered endocrine therapy with potential applications in patients whose tumors have developed resistance to earlier endocrine treatments.

Physical and Chemical Properties

Imlunestrant is a synthetic, fluorine-containing small molecule containing nitrogen, oxygen and sulfur functionalities. Its physicochemical properties are important for pharmaceutical formulation, analytical testing and solid-state characterization.

Quality and Analytical Testing

Imlunestrant API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Degradation products
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Heavy metals
  • Polymorphic characterization
  • Particle-size distribution
  • Stability testing

Storage

Imlunestrant should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive moisture, heat and direct light. Final storage requirements should be established through validated stability studies.

Pharmaceutical Research and Development

Imlunestrant is relevant to research involving estrogen receptor degradation, endocrine resistance, ER-positive breast cancer and next-generation oral endocrine therapies.

Imlunestrant API Summary

Imlunestrant is an investigational oral selective estrogen receptor degrader (SERD) with CAS Number 2361179-56-4, molecular formula C35H37F2N5O5S, and molecular weight 677.77 g/mol. It is being developed for ER-positive breast cancer and works by binding to and promoting degradation of the estrogen receptor.

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 2.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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