Description

Lcz 696 Impurity C CAS NO 149709-63-7 is a specified organic impurity associated with the active pharmaceutical ingredient Sacubitril/Valsartan, a critical heart failure medication. This compound is essential for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sacubitril/Valsartan drug substance and products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor and control impurity levels.
• Stability and Forced Degradation Studies: Employed to identify and quantify degradation products formed under various stress conditions (heat, light, humidity, acid/base).
• Quality Control and Batch Release Testing: Serves as a system suitability standard and for setting impurity acceptance criteria in routine QC testing of API and finished dosage forms.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research on Degradation Pathways: Aids in elucidating the chemical degradation mechanisms of Sacubitril/Valsartan to improve formulation stability.

Basic Information

Product Name	Lcz 696 Impurity C
CAS No.	149709-63-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Valsartan Impurity C; LCZ696 Impurity C; Sacubitril/Valsartan Impurity C; (2S,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester; AHU-377 Impurity C; Entresto Impurity C
EINECS	Contact for details

Quality Control

Our Lcz 696 Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines for impurities in new drug substances (Q3A(R2)) and are suitable for use in GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at -20°C. Handle the material under an inert atmosphere if specified to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.