Evocalcet API Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Evocalcet API Manufacturer & Supplier in India

Evocalcet is a synthetic calcimimetic active pharmaceutical ingredient (API) that acts as an allosteric activator of the calcium-sensing receptor (CaSR). It is used to regulate parathyroid hormone (PTH) secretion and is primarily associated with the treatment of secondary hyperparathyroidism in patients with chronic kidney disease undergoing dialysis.

What is Evocalcet?

Evocalcet is an orally active calcimimetic compound that increases the sensitivity of the calcium-sensing receptor to extracellular calcium. This suppresses excessive PTH secretion and helps regulate calcium and phosphorus metabolism.

CAS Number: 1264206-74-7
Molecular Formula: C₁₅H₁₃F₃N₂O
Molecular Weight: 294.27 g/mol

Mechanism of Action

Evocalcet acts as an allosteric agonist of the calcium-sensing receptor (CaSR) located on parathyroid cells.

Its pharmacological effects include:

  • Activation of calcium-sensing receptor signaling
  • Increased sensitivity of CaSR to extracellular calcium
  • Suppression of parathyroid hormone secretion
  • Reduction in circulating PTH concentrations
  • Regulation of calcium-phosphorus homeostasis

Pharmaceutical Applications

Evocalcet is used in pharmaceutical formulations for:

  • Secondary hyperparathyroidism
  • Management of elevated PTH levels in patients with chronic kidney disease undergoing dialysis
  • Regulation of mineral and bone metabolism associated with chronic kidney disease

The exact indication, dosage and patient population depend on the approved product labeling and applicable regulatory requirements.

Evocalcet API

Evocalcet is a small-molecule calcimimetic API with defined chemical and physicochemical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances, stereochemical purity and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Chiral purity
  • Water content
  • Residual solvents
  • Elemental impurities
  • Specific optical rotation, where applicable
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Evocalcet should comply with the applicable approved specification and relevant regulatory requirements.

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Store Evocalcet in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.

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 0.2%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 0.5%
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