Active Pharmaceutical Ingredients
API (Hormonal / Synthetic Progestin)
IP / BP / EP / USP / In-house Pharmaceutical Grade
C20H26O2
(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
68-22-4
298.42 g/mol
Synthetic Progestogen / Steroidal Hormone
| 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 |
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.
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.
| 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 |
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.
We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.
7 to 21 business days from dispatch, depending on your location.
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.
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