Description

Fosinopril Impurity D is a designated pharmaceutical reference standard used for the identification, qualification, and quantification of related substances in Fosinopril drug substances and finished products. This high-purity impurity is critical for ensuring the safety, efficacy, and regulatory compliance of cardiovascular medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for rigorous quality control and research and development processes.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation in QC/QA labs.
• Impurity Profiling: Identification and quantification of this specific impurity in Fosinopril active pharmaceutical ingredient (API) batches to meet ICH Q3A/B guidelines.
• Stability Studies: Monitoring the formation and levels of Fosinopril Impurity D during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Providing essential impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to agencies like the FDA and EMA.
• Process Chemistry Research: Used in R&D to understand and optimize synthesis pathways to minimize the formation of this impurity.
• Pharmacopoeial Testing: Supporting compliance testing as per USP, EP, or other pharmacopoeial monographs for Fosinopril.

Basic Information

Product Name	Fosinopril Impurity D
CAS No.	1356446-78-0
Molecular Formula	C30H46NO7P
Molecular Weight	563.67 g/mol
Synonyms	(4S)-4-Cyclohexyl-1-[[(R)-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino](phenylphosphinyl)acetyl]-L-proline; Fosinopril EP Impurity D; Fosinopril USP Impurity D; Fosinopril Related Compound D; (4S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino](phenylphosphinyl)propanoyl]-4-cyclohexyl-L-proline ethyl ester; L-Proline, 4-cyclohexyl-1-[[(R)-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino](phenylphosphinyl)acetyl]-, (4S)-
EINECS	Contact for details

Quality Control

Our Fosinopril Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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