Norethindrone Acetate is a synthetic progestin active pharmaceutical ingredient (API) widely used in hormonal therapies and women's health formulations. It is the acetate ester derivative of norethindrone and belongs to the class of synthetic steroid hormones known as progestogens.
Norethindrone Acetate exhibits potent progestational activity and is utilized in pharmaceutical formulations intended for hormone-related therapeutic applications. The molecule is extensively studied for its pharmacological properties, formulation development, analytical testing, and pharmaceutical manufacturing.
Norethindrone Acetate is an important hormonal pharmaceutical API used in the development and manufacture of various hormone-based pharmaceutical products.
Key pharmaceutical quality attributes include:
CAS Number: 51-98-9
Molecular Formula: C22H28O3
Molecular Weight: 340.46 g/mol
Chemical Name: 17α-Ethynyl-17-hydroxy-19-nor-4-androsten-3-one acetate
IUPAC Name: (17α)-17-(Acetyloxy)-19-norpregn-4-en-20-yn-3-one
Drug Class: Synthetic Progestin
Therapeutic Class: Hormonal Agent
Therapeutic Area: Women's Health
Molecule Type: Synthetic Steroidal Compound
Norethindrone Acetate functions as a synthetic progestational agent by interacting with progesterone receptors.
Its pharmacological activity includes:
Norethindrone Acetate API is relevant to:
Norethindrone Acetate belongs to the family of synthetic steroid hormones and possesses structural features characteristic of progestins.
Key characteristics include:
Norethindrone Acetate is generally described as a white to off-white crystalline powder.
Physical characteristics include:
A controlled Norethindrone Acetate API manufacturing process may involve:
Typical Norethindrone Acetate API testing may include:
Store Norethindrone Acetate API in a tightly closed container, protected from excessive moisture, heat, and direct light.
Storage conditions should comply with approved stability studies and applicable pharmaceutical specifications.
Norethindrone Acetate is widely used in research involving:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 161°C – 166°C |