Description

Norethindrone Pivalate is a synthetic progestin ester, specifically the pivalate ester of norethindrone. This compound is a key pharmaceutical intermediate in the synthesis of long-acting injectable contraceptive formulations and other advanced hormonal therapies. It is primarily utilized by pharmaceutical manufacturers and research institutions in the development and production of next-generation women's healthcare products. Its esterified structure enhances lipophilicity, which is critical for achieving sustained release profiles in depot formulations.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Primary use in the synthesis of long-acting injectable contraceptive APIs.
• Hormone Replacement Therapy (HRT): Used in the development of progestin components for HRT regimens.
• Veterinary Pharmaceuticals: Application in animal health for estrus synchronization and reproductive management.
• Pharmaceutical Research: Serves as a critical reference standard and building block in medicinal chemistry for novel progestin analogs.
• Controlled-Release Drug Delivery Systems: Explored in advanced drug delivery research due to its ester properties for implantable or microsphere-based systems.

Basic Information

Item	Details
Product Name	Norethindrone Pivalate
CAS No.	65445-09-2
Molecular Formula	C26H36O3
Molecular Weight	396.57 g/mol
Synonyms	Norethisterone Pivalate; 17α-Ethynyl-19-nortestosterone 17β-pivalate; 19-Nor-17α-pregna-4-en-20-yn-3-one, 17-(2,2-dimethyl-1-oxopropoxy)-, (17β)-; Norigest; Noristerat (brand name intermediate); 17β-Pivaloyloxy-19-nor-17α-pregna-4-en-20-yn-3-one; Norethindrone 17β-pivalate
EINECS	Contact for details

Quality Control

Our Norethindrone Pivalate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting high standards for pharmaceutical intermediates. Certificates of Analysis (COA) detailing specifications such as assay, related substances, and residual solvents are provided with every shipment. We support compliance with cGMP, ICH Q7, and relevant pharmacopeial guidelines for advanced intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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