Norethindrone, also known as Norethisterone, is a synthetic progestin belonging to the 19-nortestosterone-derived class of steroidal hormones. It is used as an active pharmaceutical ingredient in hormonal pharmaceutical formulations, particularly in products involving contraception and management of menstrual disorders.
Norethindrone has CAS Number 68-22-4, molecular formula C20H26O2, and molecular weight 298.42 g/mol. It is a well-characterized steroidal pharmaceutical compound with defined stereochemistry.
Norethindrone is a specialized steroidal progestin API used in pharmaceutical formulation development and manufacturing. Its quality evaluation includes identity, assay, related substances, water content, residue on ignition, optical rotation and other applicable pharmaceutical parameters.
CAS Number: 68-22-4
Molecular Formula: C20H26O2
Molecular Weight: 298.42 g/mol
Chemical Name: 17α-Ethynyl-17β-hydroxy-19-nor-4-androsten-3-one
Synonyms: Norethisterone, Norethynodrel
Drug Class: Progestin
Therapeutic Class: Progestogen / Hormonal Agent
Therapeutic Area: Women's Health / Endocrinology
Molecule Type: Synthetic Steroidal Small Molecule
PubChem identifies Norethindrone as CAS 68-22-4 with formula C20H26O2 and molecular weight 298.4 g/mol.
Norethindrone produces its principal pharmacological effects through interaction with progesterone receptors.
Its progestogenic activity can:
Norethindrone API is used in:
Norethindrone is a white to practically white crystalline powder. It is a steroidal compound with low aqueous solubility and is soluble in selected organic solvents.
A controlled Norethindrone API manufacturing process may involve:
Typical Norethindrone API quality-control testing may include:
Norethindrone is relevant to research involving:
Store Norethindrone API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage conditions should follow validated stability data and the applicable API specification.
| 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 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 0.5% |
| Melting Point | Approximately 216–220°C |