Description

Fosaprepitant Impurity 12 is a designated impurity of the antiemetic prodrug Fosaprepitant, identified by the CAS registry number 172673-19-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Fosaprepitant and its formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Fosaprepitant active pharmaceutical ingredient (API) and drug products.
• Essential component in analytical method development and validation (e.g., HPLC, UPLC) for Fosaprepitant manufacturing processes.
• Critical for stability studies and degradation pathway profiling to meet ICH guidelines.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity profiles and specifications.
• Supports quality control (QC) and quality assurance (QA) laboratories in routine batch release testing.
• Valuable for research and development of Fosaprepitant synthesis routes and process optimization.

Basic Information

Product Name	Fosaprepitant Impurity 12
CAS No.	172673-19-7
Molecular Formula	C23H22F7N4O6P
Molecular Weight	614.41 g/mol
Synonyms	Fosaprepitant Related Compound 12; Fosaprepitant EP Impurity J; Fosaprepitant USP Impurity; Aprepitant Phosphate Ester Impurity; 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 Phosphate Ester Impurity; 172673-19-7; Fosaprepitant Specified Impurity
EINECS	Contact for details

Quality Control

Our Fosaprepitant Impurity 12 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

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

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