Description

n-Desmethyl Ulipristal is a key pharmaceutical intermediate and an active metabolite of the selective progesterone receptor modulator (SPRM) ulipristal acetate. This compound is of critical importance for research, development, and quality control within the pharmaceutical industry. It is primarily utilized by manufacturers and research institutions focused on women's health therapeutics, analytical method development, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and development of advanced therapeutic agents targeting progesterone receptors.
• Reference Standard: Used as a certified reference material (CRM) for the analytical testing and quality control of ulipristal acetate and related drug products.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism, efficacy, and safety profile of ulipristal acetate.
• Bioanalytical Method Development: Serves as a critical standard in developing and validating HPLC, LC-MS, and other analytical methods for drug quantification in biological matrices.
• Impurity Profiling: Used to identify, quantify, and control related substance impurities in active pharmaceutical ingredient (API) batches to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., with FDA, EMA) by providing characterized material for stability studies and impurity identification reports.

Basic Information

Product Name	n-Desmethyl Ulipristal
CAS No.	159681-67-1
Molecular Formula	C28H34N2O4
Molecular Weight	462.58 g/mol
Synonyms	11β-[4-(Dimethylamino)phenyl]-17α-hydroxy-19-nor-17α-pregna-4,9-diene-3,20-dione; 17α-Hydroxy-11β-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione; Ulipristal Metabolite; CDB-4124 Metabolite; (11β,17α)-11-[4-(Dimethylamino)phenyl]-17-hydroxy-19-norpregna-4,9-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our n-Desmethyl Ulipristal is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods, purity assay by HPLC, and detailed impurity profiling to ensure it meets the stringent requirements for pharmaceutical research and development. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤1.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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