Description

N2-Losartanyl-Losartan (Losartan Impurity) is a key process-related impurity and degradation product of the antihypertensive drug Losartan. Its precise identification and quantification are critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). This high-purity reference standard is essential for pharmaceutical R&D, quality control laboratories, and regulatory compliance activities focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Losartan impurities in accordance with ICH guidelines.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods for impurity profiling.
• Quality Control & Assurance: Used in routine batch testing of Losartan API and finished dosage forms to monitor impurity levels and ensure compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as part of drug product stability testing.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing Losartan synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	N2-Losartanyl-Losartan (Losartan Impurity)
CAS No.	230971-72-9
Molecular Formula	C22H23ClN6O
Molecular Weight	422.91 g/mol
Synonyms	Losartan Impurity F (EP); Losartan N2-Losartanyl Impurity; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol, N2-Losartanyl derivative; Losartan Related Compound F; 1H-Imidazole-5-methanol, 2-butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (5-chloropentyl)carbamate; N2-(5-Chloropentyl) Losartan Carbamate
EINECS	Contact for details

Quality Control

Our N2-Losartanyl-Losartan is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization, including HPLC for purity, LC-MS for structural confirmation, and NMR for identity verification, to ensure high purity and batch-to-batch consistency. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards where applicable.

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 compound is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% 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.