Description

Losartan Impurity C (Isolosartan) is a specified impurity and a key structural isomer of the active pharmaceutical ingredient Losartan. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of Losartan-based drug products.

Application

• Primary use as a pharmaceutical 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) for regulatory filings (e.g., ANDA, NDA).
• Used in stability studies and forced degradation studies to understand the degradation pathways of Losartan.
• Essential for quality control (QC) and quality assurance (QA) laboratories to monitor impurity profiles and ensure batch-to-batch consistency.
• Serves as a research chemical in pharmacokinetic and metabolic studies related to Losartan.
• Supports regulatory compliance with pharmacopeial standards (USP, EP, ICH Q3A/B guidelines) for impurity profiling.

Basic Information

Product Name	Losartan Impurity C (Isolosartan)
CAS No.	114799-13-2
Molecular Formula	C22H23ClN6O
Molecular Weight	422.91 g/mol
Synonyms	Isolosartan; Losartan Isomer C; 2-Butyl-5-chloro-3-[[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]imidazo[4,5-b]pyridine; 2-Butyl-5-chloro-3-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-3H-imidazo[4,5-b]pyridine; 3-[[2'-(-1H-Tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-2-butyl-5-chloro-3H-imidazo[4,5-b]pyridine; Losartan Related Compound C; BIBR 277 dihydrochloride impurity C; DuP 753 Impurity C
EINECS	Contact for details

Quality Control

Our Losartan Impurity C is manufactured under strict quality systems to ensure it meets the exacting requirements for use as a reference standard. Each batch is subjected to comprehensive analytical testing, including HPLC purity, residual solvent analysis, and structural confirmation (NMR, MS). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the results against stringent in-house specifications. Our quality commitment supports compliance with ICH guidelines and global regulatory expectations.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an 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)	Individual 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.