Description

Sacubitril Impurity 3 is a specified impurity associated with the active pharmaceutical ingredient Sacubitril, a key component in cardiovascular combination therapies. This compound is critical for pharmaceutical research and development, serving as a reference standard for method validation, stability studies, and ensuring drug product purity and safety. It is primarily required by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and biotechnology sectors for rigorous impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sacubitril and its drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Sacubitril active pharmaceutical ingredient (API) and finished dosage forms to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Sacubitril Impurity 3
CAS No.	1038925-00-6
Molecular Formula	C24H29NO5
Molecular Weight	411.49 g/mol
Synonyms	AHU-377 Impurity 3; LBQ657 Impurity 3; (2R,4S)-5-([1,1'-Biphenyl]-4-yl)-4-((tert-butoxycarbonyl)amino)-2-methylpentanoic Acid Impurity; NEP Inhibitor Impurity; Sacubitril Related Compound 3; Entresto Impurity; LCZ696 Impurity 3
EINECS	Contact for details

Quality Control

Every batch of Sacubitril Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant conditions.

Specification

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