Hetrombopag Olamine API Manufacturer in India

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Hetrombopag Olamine API Manufacturer in India

Hetrombopag Olamine is a synthetic, orally active thrombopoietin receptor (TPO-R) agonist used to stimulate platelet production. It is a small-molecule pharmaceutical compound developed for the treatment of thrombocytopenia associated with conditions such as immune thrombocytopenia and severe aplastic anemia.

Hetrombopag is administered in its olamine salt form and acts by activating the thrombopoietin receptor (c-Mpl), promoting the proliferation and differentiation of megakaryocytes and increasing platelet production.

The molecular formula of Hetrombopag Olamine is C29H38N6O4 and its molecular weight is approximately 534.66 g/mol. The CAS Number is 1370889-36-7.

Hetrombopag Olamine API Overview

Hetrombopag Olamine is a non-peptide thrombopoietin receptor agonist. Unlike endogenous thrombopoietin, which is a protein hormone, Hetrombopag is a small molecule that stimulates the TPO receptor and promotes platelet production.

It is used in pharmaceutical development for oral therapies intended to increase platelet counts in patients with selected thrombocytopenic disorders.

Mechanism of Action

Hetrombopag binds to and activates the thrombopoietin receptor (TPO-R/c-Mpl) on megakaryocyte precursor cells.

TPO receptor activation stimulates intracellular signaling pathways involved in:

  • Megakaryocyte proliferation
  • Megakaryocyte differentiation
  • Platelet production
  • Increased circulating platelet counts

Pharmaceutical Applications

Hetrombopag Olamine API is used in the development and manufacture of pharmaceutical formulations for:

  • Immune thrombocytopenia
  • Severe aplastic anemia
  • Thrombocytopenia-related therapeutic research
  • Platelet-production research
  • Hematology pharmaceutical development
  • Analytical and formulation research

Hetrombopag Olamine API Manufacturing

Hetrombopag Olamine is a synthetic pharmaceutical active ingredient manufactured through controlled chemical synthesis, purification and drying processes.

Quality control may include identification, assay, related substances, residual solvents, water content, elemental impurities and other parameters specified in the applicable API specification.

Physical and Chemical Properties

Hetrombopag Olamine is a synthetic small-molecule compound supplied as a solid pharmaceutical material. Its salt form is selected for pharmaceutical development and formulation purposes.

Storage

Hetrombopag Olamine should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage should comply with the manufacturer's current CoA, SDS and validated stability requirements.

Quality Documentation

Depending on the intended pharmaceutical application, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • Analytical test report
  • Residual-solvent data
  • Stability information
  • Regulatory documentation

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%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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