Description

Aprepitant Impurity 27 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Aprepitant, an antiemetic medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and method validation.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Aprepitant API.
• Essential for method development and validation in HPLC, UPLC, and other chromatographic techniques.
• Critical component in stability studies and impurity profiling to meet ICH guidelines.
• Used in pharmaceutical research to understand degradation pathways and synthesis by-products.
• Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Employed in quality control laboratories for routine batch release testing of Aprepitant drug products.

Basic Information

Product Name	Aprepitant Impurity 27
CAS No.	2377328-02-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 27; Aprepitant EP Impurity G; Aprepitant USP Impurity; Fosaprepitant Impurity 27; MK-0869 Impurity 27; (3R,5S)-5-[(2R)-(1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy)-3-(4-fluorophenyl)morpholin-4-yl]methyl]-1H-1,2,4-triazol-5(4H)-one; Emend Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

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 inert conditions or in a desiccator to prevent degradation.

Specification

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