Description

19-Norethindrone Acetate is a synthetic progestin steroid hormone, a key pharmaceutical intermediate and active pharmaceutical ingredient (API). This compound is critical for the development of hormonal therapies, offering high biological activity and specificity. It is primarily required by pharmaceutical manufacturers and research institutions for applications in women's health, including contraceptive and hormone replacement formulations.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral contraceptives and hormone replacement therapy (HRT) products.
• Progestin Component: Used in combination with estrogen in various hormonal contraceptive formulations (pills, patches).
• Gynecological Therapeutics: Employed in the treatment of menstrual disorders, endometriosis, and abnormal uterine bleeding.
• Research & Development: Serves as a critical reference standard and intermediate in steroid chemistry and pharmacological research.
• Veterinary Medicine: Applied in animal health for estrus synchronization and reproductive management.
• Advanced Drug Delivery Systems: Incorporated into long-acting implantable or injectable contraceptive devices.

Basic Information

Product Name	19-Norethindrone Acetate
CAS No.	51-98-9
Molecular Formula	C22H28O3
Molecular Weight	340.46 g/mol
Synonyms	Norethisterone Acetate; 19-Nor-17α-ethynyltestosterone acetate; 17α-Ethynyl-19-nortestosterone acetate; Lynestrenol acetate; Norlutin acetate; Aygestin; Primolut Nor; 19-Nor-17α-ethynyl-4-androsten-17β-ol-3-one acetate
EINECS	200-108-3

Quality Control

Our 19-Norethindrone Acetate is manufactured under strict quality management systems. It undergoes rigorous analytical testing to meet high-purity standards suitable for pharmaceutical applications, including compliance with relevant pharmacopeial monographs (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to ensure traceability and quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.