Description

Fosinopril Related Compound H CAS NO 149760-14-5 is a high-purity chemical reference standard, specifically identified as a key impurity or degradation product of the active pharmaceutical ingredient Fosinopril. This compound is critical for pharmaceutical research, development, and quality control, enabling precise analytical method validation and ensuring drug purity and safety. It is primarily utilized by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the synthesis, testing, and compliance monitoring of cardiovascular medications.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying impurities in Fosinopril drug substances and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical standard to establish specificity, accuracy, and detection limits for chromatographic assays.
• Stability Studies: Employed to monitor the formation of degradation products in Fosinopril under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in metabolic studies and to understand the degradation pathways of Fosinopril.

Basic Information

Product Name	Fosinopril Related Compound H
CAS No.	149760-14-5
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 Impurity H; Fosinopril EP Impurity H; Fosinopril USP Related Compound H; Fosinopril Degradation Product; L-Proline, 4-cyclohexyl-1-[[(R)-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino](phenylphosphinyl)acetyl]-; (4S)-1-[(R)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]-1-oxo-2-phenylethylphosphinyl]-4-cyclohexyl-L-proline ethyl ester
EINECS	Contact for details

Quality Control

Our Fosinopril Related Compound H is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. Our quality commitment ensures reliability for your most critical analytical applications.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to prevent absorption of atmospheric moisture upon opening.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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