Gestodene API | Gestodene Pharmaceutical API Manufacturer in India

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

Gestodene API

Gestodene is a synthetic progestin belonging to the 19-nortestosterone derivative class of steroidal compounds. It is a potent progestational agent primarily used as a component of combined hormonal contraceptives. Gestodene exerts progestogenic activity and helps suppress ovulation when used in combination with an estrogen.

Gestodene API Manufacturer in India

Gestodene is a specialized steroidal pharmaceutical active ingredient used in the manufacture of oral hormonal contraceptive formulations. Its production requires controlled steroid synthesis, purification and comprehensive analytical characterization to ensure pharmaceutical quality.

Chemical Information

CAS Number: 60282-87-3
Molecular Formula: C21H26O2
Molecular Weight: 310.43 g/mol
Drug Class: Progestin
Pharmacological Class: Progestogen
Therapeutic Class: Hormonal Contraceptive
Therapeutic Area: Women's Health / Reproductive Health

Mechanism of Action

Gestodene acts primarily as a progesterone receptor agonist. Its progestational activity contributes to suppression of the hypothalamic-pituitary-ovarian axis, helping inhibit ovulation. It also produces changes in cervical mucus and the endometrium that contribute to contraceptive effectiveness.

Pharmaceutical Applications

Gestodene is principally used in combined oral contraceptive formulations, where it is administered together with an estrogen such as ethinylestradiol. The combination provides contraceptive activity primarily through suppression of ovulation and additional effects on cervical mucus and the endometrium.

Gestodene in Oral Contraceptives

Gestodene is a potent progestin and is used at relatively low doses in combined hormonal contraceptive products. Its high progestational potency allows it to be incorporated into low-dose oral contraceptive formulations.

Physical and Chemical Properties

Gestodene is a synthetic steroidal compound with the molecular formula C21H26O2 and molecular weight 310.43 g/mol. It is characterized by a steroid nucleus containing hydroxyl and ketone functional groups and an unsaturated side-chain structure.

Quality and Analytical Testing

Gestodene API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • LC-MS confirmation
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Optical rotation where applicable
  • Melting range

Storage

Gestodene should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Gestodene remains an important synthetic progestin in pharmaceutical research and hormonal contraceptive development. Its potent progestational activity and suitability for combination with estrogenic agents have supported its use in combined hormonal contraceptive formulations.

Gestodene API Summary

Gestodene is a synthetic steroidal progestin API used primarily in combined hormonal contraceptives. It has CAS Number 60282-87-3, molecular formula C21H26O2, and molecular weight 310.43 g/mol. Its principal pharmacological action is progesterone receptor agonism, contributing to suppression of ovulation and contraceptive activity.

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%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point Approximately 190–195°C
Get Bulk Quote via WhatsApp