Description

Lcz-696 Impurity 22 is a specified impurity and a key chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sacubitril/Valsartan (LCZ696). This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sacubitril/Valsartan (LCZ696) drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, validating, and transferring high-performance liquid chromatography (HPLC/UPLC) and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor impurity profiles and degradation pathways during forced degradation and long-term stability testing of LCZ696 formulations.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry R&D: Aids in the optimization of synthesis and purification processes by tracking the formation and clearance of this specific impurity.
• Quality Control Testing: Serves as a system suitability and calibration standard in routine batch release testing of LCZ696 active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Lcz-696 Impurity 22
CAS No.	1817838-91-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	LCZ696 Impurity 22; Sacubitril/Valsartan Impurity 22; Entresto Impurity 22; (2R,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester impurity; AHU-377/Valsartan Impurity 22; NEP/ARB inhibitor impurity; 1817838-91-7
EINECS	Contact for details

Quality Control

Our Lcz-696 Impurity 22 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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