Description

Fosinopril Impurity C is a designated pharmaceutical reference standard critical for analytical research and development. This compound is essential for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Fosinopril, an angiotensin-converting enzyme (ACE) inhibitor. It serves as a key marker for identifying and quantifying process-related impurities during manufacturing. This high-purity standard is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Fosinopril Impurity C in bulk drug substances and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing protocols.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Chemical Research: Acts as a building block or intermediate for synthetic chemists researching novel analogs or degradation pathways of Fosinopril.

Basic Information

Product Name	Fosinopril Impurity C
CAS No.	474519-28-3
Molecular Formula	C30H46NO7P
Molecular Weight	563.66 g/mol
Synonyms	(4S)-4-Cyclohexyl-1-[[(R)-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino](phenyl)phosphinyl]acetyl]-L-proline; Fosinopril EP Impurity C; Fosinopril USP Impurity C; Fosinopril Related Compound C; L-Proline, 4-cyclohexyl-1-[[(R)-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino](phenyl)phosphinyl]acetyl]-, (4S)-; Phosphinic acid, [[1-(ethoxycarbonyl)-3-phenylpropyl]amino]phenylacetyl-, (4S)-4-cyclohexyl-1-ester with L-proline
EINECS	Contact for details

Quality Control

Our Fosinopril Impurity C is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to guarantee consistency and reliability. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with ICH guidelines. Our quality commitment supports your compliance with cGMP, USP, and EP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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