Nomegestrol API Manufacturer in India

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Nomegestrol API

Nomegestrol is a synthetic steroidal progestogen and a derivative of 19-norprogesterone. It is the parent compound of nomegestrol acetate and has a defined steroidal structure with progestogenic activity.

Nomegestrol has the CAS Number 58691-88-6, molecular formula C21H28O3, and molecular weight 328.40 g/mol. Its chemical identity is documented in PubChem and FDA Global Substance Registration System records.

Nomegestrol API Manufacturer in India

Nomegestrol is a specialized steroidal pharmaceutical compound relevant to progestogen research, hormonal pharmaceutical development and analytical applications.

Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, optical rotation and solid-state characteristics, according to the applicable API specification.

Chemical Information

CAS Number: 58691-88-6

Molecular Formula: C21H28O3

Molecular Weight: 328.40 g/mol

Chemical Name: 17-Hydroxy-6-methyl-19-norpregna-4,6-diene-3,20-dione

Synonyms: 19-Normegestrol; Nomegestrolum

Drug Class: Progestogen

Therapeutic Class: Hormonal / Progestogenic Compound

Molecule Type: Synthetic Small Molecule

PubChem CID: 68783

FDA UNII: 10F89177CO

ChEMBL ID: CHEMBL2105722

These identifiers are reported by PubChem and associated authoritative databases.

Mechanism of Action

Nomegestrol is a progestogenic steroid that acts primarily through interaction with progesterone receptors. Activation of progesterone-receptor pathways influences transcription of progesterone-responsive genes and produces characteristic progestogenic effects.

Nomegestrol should not be confused with nomegestrol acetate, which is its acetate ester and a separate pharmaceutical substance. Nomegestrol acetate has CAS 58652-20-3, formula C23H30O4, and molecular weight 370.48 g/mol.

Pharmaceutical Applications

Nomegestrol is relevant to:

  • Progestogen pharmaceutical research
  • Steroidal hormone research
  • Progesterone receptor research
  • Hormonal drug development
  • Pharmaceutical formulation research
  • Analytical method development
  • Reference-standard and impurity research
  • Pharmaceutical quality-control testing

Physical Characteristics

Nomegestrol is a steroidal crystalline small molecule. PubChem reports a molecular weight of 328.40 g/mol, XLogP3-AA of 2.0, and topological polar surface area of 54.4 Ų.

Nomegestrol is also identified as impurity B in the European Pharmacopoeia monograph for nomegestrol acetate, providing an important analytical connection between the parent compound and the acetate pharmaceutical substance.

Pharmaceutical Research

Nomegestrol is relevant to research involving:

  • Progesterone receptor activity
  • Progestogenic compounds
  • Steroidal hormone pharmacology
  • Reproductive pharmacology
  • Endocrine research
  • Hormonal drug development
  • Steroid chemistry
  • Pharmaceutical analytical research
  • Related-substance and impurity analysis

Quality Control Testing

Typical Nomegestrol API quality-control testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Organic impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Specific optical rotation
  • Melting-point characterization
  • Solid-state characterization
  • Stability testing

Final numerical acceptance criteria should be based on the applicable validated API specification.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.2%
Individual Impurity NMT 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 0.5%
Melting Point Approximately 220–224°C
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