Description

Lcz 696 Impurity B is a specified impurity of the cardiovascular drug Sacubitril/Valsartan (LCZ696). This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sacubitril/Valsartan (LCZ696) active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and drug product meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light) to establish shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Process Chemistry Research: Aids in optimizing synthetic routes and purification processes to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Lcz 696 Impurity B
CAS No.	766480-48-2
Molecular Formula	C24H28N4O5
Molecular Weight	452.50 g/mol
Synonyms	Valsartan Impurity B; Sacubitril/Valsartan Impurity B; LCZ696 Impurity B; (2S,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid pentylamide; AHU-377 Impurity B; N-[(2S,4S)-5-Biphenyl-4-yl-4-(3-carboxypropionylamino)-2-methylpentanoyl]pentylamine; Entresto Impurity B
EINECS	Contact for details

Quality Control

Our Lcz 696 Impurity B is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with detailed chromatographic data is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.