Description

Sacubitril Impurity 31 is a designated impurity of the active pharmaceutical ingredient Sacubitril, a key component in cardiovascular combination therapies. This compound is critical for pharmaceutical research and development, specifically for method development, stability studies, and ensuring the quality and safety of the final drug product. It is an essential reference standard for analytical laboratories and manufacturers involved in the production and quality control of Sacubitril and its related drug formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sacubitril API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies & Forced Degradation: Employed to understand the degradation pathways of Sacubitril and to establish stability-indicating methods.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting impurity acceptance criteria in pharmaceutical quality control laboratories.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization data.
• Research on Synthesis Pathways: Used in chemical research to study and optimize the synthesis and purification processes of Sacubitril.

Basic Information

Product Name	Sacubitril Impurity 31
CAS No.	2376611-98-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,4S)-5-([1,1'-Biphenyl]-4-yl)-4-((tert-butoxycarbonyl)amino)-2-methylpentanoic acid; Boc-Sacubitril; AHU-377 Impurity; LCZ696 Impurity; Entresto Impurity; Neprilysin Inhibitor Impurity; (2R,4S)-4-[[(1,1-Dimethylethoxy)carbonyl]amino]-5-(4-phenylphenyl)-2-methylpentanoic acid; Sacubitril Related Compound 31
EINECS	Contact for details

Quality Control

Our Sacubitril Impurity 31 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for purity (by HPLC), identity (by IR and/or MS), and other relevant physicochemical tests. Our quality system is designed to support GMP/GLP-compliant applications in pharmaceutical research and development.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.