Description

Fosaprepitant Impurity 5 CAS NO 327623-35-8 is a designated impurity standard of the antiemetic prodrug Fosaprepitant. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to monitor and control impurities, ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fosaprepitant active pharmaceutical ingredient (API) and its formulations.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure API purity.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Fosaprepitant.

Basic Information

Product Name	Fosaprepitant Impurity 5
CAS No.	327623-35-8
Molecular Formula	C23H22F7N4O6P
Molecular Weight	614.41 g/mol
Synonyms	Fosaprepitant Related Compound 5; Fosaprepitant EP Impurity 5; Fosaprepitant USP Impurity 5; (2S,3S)-3-({(2R)-1-[3,5-Bis(trifluoromethyl)phenyl]-3-(4-fluorophenyl)-2-oxo-2,3-dihydro-1H-imidazol-4-yl}methyl)-5-oxo-2-phenylmorpholin-4-yl methyl hydrogen phosphate; Aprepitant Phosphate Ester Impurity; L-758,298 Impurity
EINECS	Contact for details

Quality Control

Our Fosaprepitant Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary 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 should be kept in a desiccated environment to prevent moisture absorption.

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%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%
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.