Description

Sacubitril Impurity 7 CAS NO 149709-44-4 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Sacubitril, a key component in cardiovascular medications. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in Sacubitril API and related drug formulations.
• Analytical Method Development and Validation for HPLC, LC-MS, and other chromatographic techniques.
• Quality Control and Release Testing of Sacubitril bulk drug substances and finished dosage forms.
• Stability Studies to monitor the formation and levels of this specific impurity over time.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development of new synthetic pathways and purification processes for Sacubitril.
• Reference Standard for Pharmacopoeial Testing to meet USP, EP, or other compendial requirements.

Basic Information

Product Name	Sacubitril Impurity 7
CAS No.	149709-44-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sacubitril Related Compound 7; LCZ696 Impurity 7; Entresto Impurity 7; AHU-377 Impurity 7; (2R,4S)-5-([1,1'-Biphenyl]-4-yl)-4-((tert-butoxycarbonyl)amino)-2-methylpentanoic Acid Impurity; NEP Inhibitor Impurity; Neprilysin Inhibitor Impurity 7; Sacubitril Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Sacubitril Impurity 7 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic methods, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing specifications and test results. We support compliance with ICH guidelines and can supply material suitable for use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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