Description

Losartan Impurity 4 is a designated impurity of the widely prescribed antihypertensive drug Losartan Potassium. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Losartan-based drug substances and products. This high-purity standard is primarily used by analytical laboratories, quality assurance departments, and research scientists in the pharmaceutical and biotechnology industries.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Losartan Potassium API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) to meet ICH Q2(R1) and pharmacopeial guidelines.
• Used in stability studies and forced degradation studies to understand the degradation pathways of Losartan.
• Essential for quality control and batch release testing in pharmaceutical manufacturing to ensure compliance with regulatory specifications.
• Valuable tool for pharmacological and toxicological research to study the profile and impact of drug-related impurities.
• Serves as a system suitability standard in regulatory submissions (e.g., ANDA, NDA) to regulatory bodies like the US FDA and EMA.

Basic Information

Product Name	Losartan Impurity 4
CAS No.	141949-90-8
Molecular Formula	C22H23ClN6O
Molecular Weight	422.91 g/mol
Synonyms	Losartan Impurity J; Losartan Related Compound J; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol; Losartan EP Impurity J; Losartan USP Impurity J; Losartan Carbinol; 5-[(2'-Butyl-4-chloro-5-(hydroxymethyl)-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole
EINECS	Contact for details

Quality Control

Our Losartan Impurity 4 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results, chromatograms, and spectral data. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). The compound is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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