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Norethisterone Structure

Product Type

API (Hormonal / Synthetic Progestin)

Grade

IP / BP / EP / USP / In-house Pharmaceutical Grade

Chemical Formula

C20H26O2

IUPAC Name

(8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one

CAS NO

68-22-4

Molecular Weight

298.42 g/mol

Chemical Class

Synthetic Progestogen / Steroidal Hormone

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white crystalline powder
Solubility Insoluble in water; soluble in ethanol, chloroform, and acetone; dissolves readily in typical organic solvents used for hormonal APIs
Melting point 203–206°C

Product Description

Norethisterone (Norethindrone) is a potent synthetic oral progestin used in various women's health formulations. It serves as an active ingredient in progestin-only and combined oral contraceptives, hormone replacement therapy (HRT), treatments for menstrual disorders, and management of endometriosis. With strong progestational activity, high oral bioavailability, and excellent stability, it is a globally preferred hormone API.

How Norethisterone Works

Norethisterone mimics natural progesterone by binding to progesterone receptors, suppressing ovulation, thickening cervical mucus to prevent sperm penetration, regulating endometrial growth, and stabilizing menstrual cycles. It also reduces menstrual pain and excessive bleeding, making it valuable in hormonal therapies.

Use(s)

Adverse Effects

Why choose Salius for Norethisterone?

  1. GMP-Compliant Manufacturing Standards
    Manufactured in WHO GMP, ISO 9001:2015, and FDA-audited facilities under strict quality control protocols. Each batch undergoes complete testing for purity and potency.
  2. Cost-Effectiveness
    Salius Pharma ensures globally competitive pricing while maintaining premium quality standards, supporting affordability in both regulated and semi-regulated markets.
  3. Global Export Experience & Documentation Support
    Comprehensive regulatory documentation (DMF, impurity profile, stability data, and validation reports) available to support international submissions.
  4. Documents We Provide
  5. Transparency & Trustworthiness
    Recognized as a Star Export House with consistent reliability, regulatory compliance, and customer satisfaction worldwide.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost-competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

It acts by mimicking natural progesterone, inhibiting ovulation, thickening cervical mucus, stabilizing the endometrial lining, and reducing menstrual bleeding.

The API follows ICH Q1A stability conditions and should be stored in a dry, cool place, protected from light and moisture.

Typically between 36 and 60 months, depending on packaging material and storage environment.

As a hormone API, microbial limits are tightly controlled per pharmacopeial specifications for oral dosage forms.

It is metabolized primarily in the liver to active and inactive metabolites, with excretion occurring mainly via urine.

Approved worldwide as a safe and effective progestin. Regulatory submissions vary by dosage form and combination product.

Place an Order or Request a Quote from Salius Pharma

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