Description

Des(4-Cyclohexyl-L-Proline) Fosinopril Acetic Acid is a key pharmaceutical intermediate and impurity reference standard used in the synthesis and quality control of Fosinopril, an angiotensin-converting enzyme (ACE) inhibitor. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in cardiovascular drug development and production.

Application

• Pharmaceutical Intermediate: A critical building block in the multi-step synthesis of the antihypertensive drug Fosinopril Sodium.
• Reference Standard: Used as a certified impurity standard in HPLC and LC-MS methods for the quality control and stability testing of Fosinopril API and finished dosage forms.
• Process Development & Validation: Essential for research and development (R&D) scientists optimizing synthetic routes and validating manufacturing processes according to ICH guidelines.
• Regulatory Compliance: Supports regulatory filings (e.g., DMF, CMC sections) by providing a characterized impurity for identification and quantification in compliance with FDA, EMA, and other global health authority requirements.
• Metabolite Studies: Utilized in pharmacokinetic and metabolic pathway research related to Fosinopril.

Basic Information

Product Name	Des(4-Cyclohexyl-L-Proline) Fosinopril Acetic Acid
CAS No.	128948-00-5
Molecular Formula	C29H45NO7P
Molecular Weight	550.64 g/mol
Synonyms	(4S)-4-Cyclohexyl-1-[[(2S)-1-oxo-2-[[hydroxy(4-phenylbutyl)phosphinyl]acetyl]amino]pentyl]-L-proline; Fosinopril Impurity C; Fosinopril Des-Cyclohexyl Proline; Des(4-Cyclohexylproline) Fosinopril; SQ 27,519; L-Proline, 4-cyclohexyl-1-[[2-[[[hydroxy(4-phenylbutyl)phosphinyl]acetyl]amino]-1-oxopentyl]]-; Fosinopril Related Compound C
EINECS	Contact for details

Quality Control

Our Des(4-Cyclohexyl-L-Proline) Fosinopril Acetic Acid is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results, ensuring compliance with the stringent standards required for pharmaceutical intermediates and reference materials.

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 atmosphere or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%
Total Impurities	≤ 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.