Description

Aprepitant Impurity 19 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Aprepitant. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aprepitant Impurity 19 in drug substance and drug product testing.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for Aprepitant.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability programs.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and purification of Aprepitant.

Basic Information

Product Name	Aprepitant Impurity 19
CAS No.	1333995-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 19; Aprepitant EP Impurity J; Aprepitant USP Impurity; Fosaprepitant Impurity; (3R)-1-[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholin-4-yl]propan-1-one; Emend Impurity; MK-0869 Impurity; Neurokinin-1 Receptor Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 19 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

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 conditions to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.