Description

Sacubitril Impurity 72 is a designated process-related impurity used in the synthesis and quality control of the active pharmaceutical ingredient Sacubitril. This compound is critical for analytical reference and method development, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Sacubitril API batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Sacubitril API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate control over the manufacturing process.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Sacubitril to minimize the formation of this impurity.

Basic Information

Product Name	Sacubitril Impurity 72
CAS No.	1361408-16-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	AHU-377 Impurity 72; LCZ696 Impurity 72; Entresto Impurity 72; Sacubitril Related Compound 72; (2R,4S)-5-Biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester impurity; N-[3-(1H-tetrazol-5-yl)-1-biphenyl-4-ylmethyl-propyl]-N-pentanoyl-N'-[2-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-succinamic acid ethyl ester impurity
EINECS	Contact for details

Quality Control

Our Sacubitril Impurity 72 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitability for its intended use as a pharmaceutical reference standard.

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 solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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