Etonogestrel is a synthetic progestin and active pharmaceutical ingredient (API) used primarily for hormonal contraception. It is a biologically active metabolite of desogestrel and belongs to the 19-nortestosterone-derived progestin class.
Etonogestrel provides progestogenic activity and is used in long-acting reversible contraceptive formulations, particularly subdermal contraceptive implants.
Etonogestrel is a synthetic steroidal progestin with high affinity for progesterone receptors. It is used as the active component of certain contraceptive implants designed to provide prolonged pregnancy prevention.
CAS Number: 54048-10-1
Molecular Formula: C₂₂H₂₈O₂
Molecular Weight: 324.46 g/mol
Etonogestrel produces contraceptive effects primarily through progesterone-receptor activity. In contraceptive implants, it continuously releases the progestin, which primarily suppresses ovulation.
Its contraceptive effects include:
Etonogestrel is used in pharmaceutical formulations for:
The exact formulation and therapeutic application depend on the approved product and applicable regulatory labeling.
Etonogestrel is a steroidal progestin 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:
Pharmaceutical-grade Etonogestrel should comply with the applicable approved specification, pharmacopoeial requirements where applicable, and relevant regulatory standards.
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.
Store Etonogestrel in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.
| 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 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |