Description

Aprepitant Impurity 6 is a specified impurity of the antiemetic drug Aprepitant, identified by the CAS number 170902-81-5. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical method development and validation required for drug substance quality control. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Aprepitant active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aprepitant Impurity 6 in drug substances and products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Aprepitant batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Aprepitant synthesis, helping to optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Aprepitant Impurity 6
CAS No.	170902-81-5
Molecular Formula	C23H21F7N4O3
Molecular Weight	534.43 g/mol
Synonyms	5-[[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one; Aprepitant Related Compound; Aprepitant EP Impurity F; Aprepitant USP Related Compound; (3aR,4S,7aS)-4-[[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]methyl]-6-(4-fluorophenyl)-2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3(2H)-dione (isomeric form); EMEND Impurity; MK-0869 Impurity
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 6 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. Certificates of Analysis (COA) with detailed chromatographic data are provided, ensuring traceability and compliance with current pharmacopeial standards and ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is hygroscopic (moisture-sensitive) and must be protected from humidity 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)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.