Description

Ulipristal Acetate n-Oxide Impurity is a specified impurity and a key oxidative degradation product of the active pharmaceutical ingredient Ulipristal Acetate. This compound is critical for pharmaceutical research, development, and quality control, serving as a reference standard for method validation and impurity profiling. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of oxidative impurities in Ulipristal Acetate drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor degradation pathways.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to profile and track impurity formation during forced degradation and long-term stability studies of Ulipristal Acetate.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity understanding and control.
• Process Chemistry Research: Aids in understanding and mitigating oxidative degradation during API synthesis, purification, and formulation processes.

Basic Information

Item	Details
Product Name	Ulipristal Acetate n-Oxide Impurity
CAS No.	1927850-00-7
Molecular Formula	C30H37NO5
Molecular Weight	491.62 g/mol
Synonyms	Ulipristal Acetate N-Oxide; Ulipristal Acetate Impurity N-Oxide; (8S,11R,13S,14S,17R)-17-Acetyl-11-[4-(dimethylamino)phenyl]-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl 4-[(dimethylamino)carbonyl]-2-fluorobenzoate N-Oxide; Ulipristal Acetate Related Compound N-Oxide; Esmya Impurity N-Oxide; CDB-4124 N-Oxide Impurity
EINECS	Contact for details

Quality Control

Our Ulipristal Acetate n-Oxide Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive). For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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