Fadrozole API Manufacturer & Supplier in India

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Fadrozole API Manufacturer & Supplier in India

Fadrozole is a synthetic non-steroidal aromatase inhibitor and active pharmaceutical ingredient (API). It inhibits the enzyme aromatase, which is responsible for the conversion of androgens into estrogens. Fadrozole has been investigated for its potential use in hormone-dependent cancers, particularly breast cancer.

What is Fadrozole?

Fadrozole is a potent, selective inhibitor of aromatase (CYP19A1). By reducing estrogen biosynthesis, it can decrease estrogen-dependent stimulation of certain tissues and tumors.

CAS Number: 102676-47-1
Molecular Formula: C₁₇H₁₉N₅
Molecular Weight: 293.37 g/mol

Mechanism of Action

Fadrozole inhibits aromatase, the enzyme responsible for the final step in estrogen biosynthesis.

Its pharmacological effects include:

  • Inhibition of aromatase activity
  • Reduction of estrogen synthesis
  • Decreased circulating estrogen concentrations
  • Reduction of estrogen-dependent stimulation
  • Potential inhibition of growth of hormone-dependent tumor cells

Pharmaceutical Applications

Fadrozole has been investigated primarily for:

  • Hormone-dependent breast cancer
  • Estrogen-dependent malignancies
  • Aromatase inhibition research
  • Endocrine oncology research

Regulatory status and approved indications should be verified for the applicable market before making therapeutic or commercial claims.

Fadrozole API

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

Typical quality evaluation may include:

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

Quality & Regulatory Considerations

Pharmaceutical-grade Fadrozole 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 Fadrozole 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) NLT 98.0% by HPLC
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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