Description

Norethindrone CAS NO 68-22-4 is a synthetic progestin steroid hormone, also known as norethisterone. This active pharmaceutical ingredient (API) is a cornerstone in hormonal therapy, valued for its potent progestational and anti-estrogenic properties. It is a critical raw material for pharmaceutical manufacturers developing products for hormonal regulation, contraception, and gynecological treatments.

Application

• Primary active ingredient in oral contraceptive pills and hormonal birth control formulations.
• Key component in hormone replacement therapy (HRT) for managing menopausal symptoms.
• Used in the treatment of gynecological disorders such as endometriosis, abnormal uterine bleeding, and amenorrhea.
• Essential in the manufacture of emergency contraceptive products.
• Utilized in veterinary medicine for estrus synchronization and reproductive management in animals.
• Serves as a crucial intermediate in the synthesis of other, more complex steroidal drugs.
• Employed in clinical research and diagnostic applications related to endocrinology.

Basic Information

Product Name	Norethindrone
CAS No.	68-22-4
Molecular Formula	C₂₀H₂₆O₂
Molecular Weight	298.42 g/mol
Synonyms	Norethisterone; 17α-Ethynyl-19-nortestosterone; 19-Nor-17α-ethynyltestosterone; 17α-Ethynyl-17β-hydroxy-4-estren-3-one; Norlutin; Primolut N; Aygestin; Micronor; Nor-QD; NET
EINECS	200-687-5

Quality Control

Our Norethindrone is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and JP. Each batch undergoes comprehensive analytical testing including identification, purity assay, and impurity profiling to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and quality assurance for our B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment away from direct light exposure to maintain stability and potency.

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 dried basis)
Loss on Drying	≤ 0.5%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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