Description

Losartan Imidazo[1,5-B]Isoquinoline Impurity is a specified organic compound used as a critical reference standard in pharmaceutical development and quality control. This impurity is essential for monitoring and controlling the purity profile of the active pharmaceutical ingredient Losartan, an angiotensin II receptor antagonist used to treat hypertension. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Losartan API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure Losartan products meet pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to understand the degradation pathways and metabolism of Losartan.

Basic Information

Product Name	Losartan Imidazo[1,5-B]Isoquinoline Impurity
CAS No.	165276-38-0
Molecular Formula	C22H23ClN6
Molecular Weight	406.91 g/mol
Synonyms	Losartan Impurity F; Losartan Related Compound F; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazo[1,5-b]isoquinoline; 1H-Imidazo[1,5-b]isoquinoline, 2-butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-; Losartan Imidazoisoquinoline Impurity; Losartan EP Impurity F; Losartan USP Impurity F
EINECS	Contact for details

Quality Control

Every batch of Losartan Imidazo[1,5-B]Isoquinoline Impurity is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)
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.