Description

Ulipristal Impurity 2 is a specified impurity and reference standard used in the quality control of Ulipristal Acetate, a selective progesterone receptor modulator. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ulipristal Acetate API.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve synthetic processes for impurity minimization.

Basic Information

Item	Details
Product Name	Ulipristal Impurity 2
CAS No.	1655514-74-1
Molecular Formula	C29H35NO4
Molecular Weight	461.60 g/mol
Synonyms	Ulipristal Related Compound 2; Ulipristal EP Impurity B; Ulipristal Acetate Impurity 2; (8S,11R,13S,14S,17R)-17-Acetyl-11-[4-(dimethylamino)phenyl]-13-methyl-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl acetate; 17β-Acetoxy-11β-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione
EINECS	Contact for details

Quality Control

Our Ulipristal Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and control of residual solvents and other specified impurities to ensure compliance with pharmacopeial standards. A comprehensive 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 a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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