Description

Sacubitril is a potent and selective neprilysin inhibitor, a key active pharmaceutical ingredient (API) in combination therapies for cardiovascular conditions. Its primary commercial value lies in its critical role in the manufacture of Entresto® (sacubitril/valsartan), a leading medication for the treatment of heart failure with reduced ejection fraction. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of advanced cardiovascular therapeutics and novel drug development.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the synthesis of the blockbuster combination drug Entresto® (sacubitril/valsartan) for chronic heart failure.
• Pharmaceutical R&D: Serves as a reference standard and a key intermediate in research programs targeting neprilysin inhibition for cardiovascular and renal diseases.
• Generic Drug Manufacturing: Critical starting material for companies developing and producing generic versions of sacubitril/valsartan combination products.
• Formulation Development: Used in the development of various dosage forms, including tablets, where precise API quality is paramount for bioavailability and stability.
• Clinical Trial Material: Supplied as a high-purity compound for the production of materials used in clinical studies for new therapeutic applications.

Basic Information

Item	Detail
Product Name	Sacubitril
CAS No.	1038924-61-6
Molecular Formula	C24H29NO5
Molecular Weight	411.49 g/mol
Synonyms	AHU-377; (2R,4S)-5-([1,1'-Biphenyl]-4-yl)-4-[(3-carboxypropanoyl)amino]-2-methylpentanoic acid; N-[2-[(1S,3R)-1-([1,1'-Biphenyl]-4-ylmethyl)-3-ethoxy-3-oxopropyl]cyclopentyl]carbonyl]-L-β-homoglutamic acid; LCZ-696 component; Entresto component; Sacubitrilum
EINECS	Contact for details

Quality Control

Our Sacubitril is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing, including HPLC for purity and assay, control of related substances, and residual solvent analysis. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with agreed specifications. We support compliance with ICH Q7 guidelines and can tailor quality attributes to meet specific pharmacopeial or client requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.10%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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