Description

Sacubitril Impurity 57 is a designated impurity associated with 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 purity and safety of the final drug product. It is an essential reference standard for quality control laboratories and analytical scientists working in the pharmaceutical industry to meet stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sacubitril and its related substances.
• Analytical Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to detect and quantify impurities in Sacubitril drug substance and finished products.
• Stability Indicating Studies: Employed in forced degradation studies to identify and track impurity formation under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release: Serves as a system suitability standard and for setting specification limits in the quality control testing of Sacubitril active pharmaceutical ingredient (API).
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Research on Degradation Pathways: Aids in understanding the chemical degradation pathways of Sacubitril, helping to improve formulation stability.

Basic Information

Product Name	Sacubitril Impurity 57
CAS No.	1038925-30-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	AHU-377 Impurity 57; LCZ696 Impurity 57; (2R,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester impurity; Entresto Impurity 57; Sacubitril Related Compound 57; UNII-Contact for details; 1,1'-Biphenyl-4-acetic acid, α-[[(1S,3R)-1-(ethoxycarbonyl)-3-methylbutyl]amino]-γ-oxo-, (αR)- isomer
EINECS	Contact for details

Quality Control

Our Sacubitril Impurity 57 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 from tests such as HPLC purity, related substances, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH Q3A, Q3B, and pharmacopeial standards for pharmaceutical impurities.

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. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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