Description

Fosinopril Related Compound D is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Fosinopril through precise identification and quantification of impurities. It is an essential material for pharmaceutical R&D laboratories, quality control departments, and regulatory compliance teams engaged in method development and validation.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Fosinopril drug substance and finished products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Fosinopril formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Used in academic and industrial research to study the metabolism, degradation pathways, and chemical behavior of Fosinopril.

Basic Information

Product Name	Fosinopril Related Compound D
CAS No.	1356353-41-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fosinopril Impurity D; Fosinopril EP Impurity D; Fosinopril Related Substance D; (4S)-4-Cyclohexyl-1-[[(R)-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino](phenylphosphinyl)acetyl]oxy]-L-proline Related Compound; Fosinopril Process Impurity; Fosinopril Degradant
EINECS	Contact for details

Quality Control

Our Fosinopril Related Compound D 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. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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