Description

Aprepitant Impurity B Enantiomer Hydrochloride is a high-purity chiral reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This specific enantiomer is essential for ensuring the stereochemical purity of Aprepitant, a neurokinin-1 (NK1) receptor antagonist used as an antiemetic. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and regulatory affairs teams for impurity profiling, method validation, and compliance documentation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the specific enantiomeric impurity in Aprepitant drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stereoselective analytical methods, such as chiral HPLC or UPLC, to monitor enantiomeric purity.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substance and product meet stringent regulatory specifications for impurity limits.
• Regulatory Submission & Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing characterized impurity standards for stability studies and impurity qualification reports.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the behavior of specific enantiomeric impurities.
• Pharmacopoeial Testing: Applicable for testing against monographs in USP, EP, or other pharmacopoeias that specify control of enantiomeric impurities.

Basic Information

Product Name	Aprepitant Impurity B Enantiomer Hydrochloride
CAS No.	183901-47-5
Molecular Formula	C23H22ClF7N4O3 • HCl
Molecular Weight	633.80 g/mol (for hydrochloride salt)
Synonyms	5-[[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-1-one Hydrochloride; (R)-Aprepitant Morpholine Impurity B Hydrochloride; Aprepitant Enantiomeric Impurity B HCl; Aprepitant EP Impurity B Enantiomer HCl; Aprepitant USP Impurity B Enantiomer Hydrochloride; Fosaprepitant Impurity B Enantiomer Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity B Enantiomer Hydrochloride is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like chiral HPLC, NMR, and MS to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Enantiomeric Purity (Chiral HPLC)	≥ 99.0%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
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.