Description

Aprepitant Impurity 15 is a designated impurity standard used in the pharmaceutical development and quality control of Aprepitant, a neurokinin-1 (NK1) receptor antagonist. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Aprepitant API and finished drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to detect and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure product consistency per ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification in regulatory filings (e.g., for FDA, EMA).
• Research and Development: Utilized in synthetic chemistry research to understand impurity formation pathways and optimize purification processes.

Basic Information

Item	Detail
Product Name	Aprepitant Impurity 15
CAS No.	1447693-83-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 15; Aprepitant EP Impurity 15; Aprepitant USP Impurity 15; (3aS)-2-[(R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-8-methyl-4,5-dihydro-3H-pyrido[2,1-c][1,4]oxazin-4-one; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 15 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (IR, MS, NMR) to ensure identity and purity. A comprehensive Certificate of Analysis (COA) is supplied with each product, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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