Description

Sacubitril Impurity 19 (CAS NO 2216746-87-9) is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Sacubitril. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific process-related impurity. It is primarily used in research and development, method validation, and stability studies for heart failure medications containing Sacubitril.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Sacubitril API and its drug products.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Critical for routine QC testing in API and finished drug product manufacturing to monitor impurity levels and ensure specifications are met.
• Stability Studies: Employed to track the formation and level of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing against monographs in pharmacopoeias such as USP, EP, or ChP where specified.

Basic Information

Product Name	Sacubitril Impurity 19
CAS No.	2216746-87-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sacubitril Related Compound 19; LCZ696 Impurity 19; Entresto Impurity 19; (2R,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester impurity; AHU-377 Impurity 19; Sacubitril Process Impurity 19; NEP Inhibitor Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Sacubitril Impurity 19 is manufactured under strict quality management systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality control protocols are designed to meet the exacting standards of the pharmaceutical industry. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (HPLC, IR), assay (HPLC), and impurity profile. We support compliance with ICH, GMP, and ISO 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 must be kept under inert conditions or in a desiccator to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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