Description

Losartan Impurity 15 is a specified impurity associated with the active pharmaceutical ingredient Losartan, an angiotensin II receptor antagonist used to treat hypertension. This impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by R&D laboratories, quality control units, and analytical service providers in the global pharmaceutical industry for method development, validation, and reference standard qualification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Losartan drug substances and products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Serves as a system suitability standard and for routine impurity testing in QC laboratories to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and quantify degradation products of Losartan.
• Research and Development: Used in synthetic chemistry research to understand the formation pathways and to develop purification processes to minimize this impurity.

Basic Information

Product Name	Losartan Impurity 15
CAS No.	914465-66-0
Molecular Formula	C22H23ClN6
Molecular Weight	406.91 g/mol
Synonyms	Losartan Related Compound 15; Losartan EP Impurity J; Losartan USP Impurity; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol; 5-[(2'-Butyl-4-chloro-5-(hydroxymethyl)-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-carbonitrile; BIBR 277 dihydrochloride impurity; EXP 3174 analog
EINECS	Contact for details

Quality Control

Every batch of Losartan Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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) and must be kept under inert conditions or in a desiccator to prevent degradation upon absorption of atmospheric moisture.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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