Description

N1-Losartanyl-Losartan (Losartan Impurity) is a key process-related impurity and degradation product of the antihypertensive drug Losartan. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, stability studies, and ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of N1-Losartanyl-Losartan in Losartan Potassium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Losartan batches meet pharmacopeial (USP, EP) specifications for related substances.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and control strategies.
• Research & Development: Supports research into the degradation pathways and metabolism of Losartan.

Basic Information

Product Name	N1-Losartanyl-Losartan (Losartan Impurity)
CAS No.	230971-71-8
Molecular Formula	C22H23ClN6O
Molecular Weight	422.91 g/mol
Synonyms	Losartan Impurity F; Losartan EP Impurity F; Losartan USP Impurity F; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol; 5-(4'-((2-Butyl-4-chloro-5-(hydroxymethyl)-1H-imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole; N1-Hydroxymethyl Losartan; BIBR 277 dihydroxymethyl analog
EINECS	Contact for details

Quality Control

Our N1-Losartanyl-Losartan is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for purity (HPLC), identity (IR, NMR), and related substances. We support compliance with major pharmacopeial standards, and specifications can be aligned with USP, EP, or in-house reference standards upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
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.