Description

Losartan Impurity 7 is a specified impurity and degradation product of the 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 scientists and quality assurance professionals in the pharmaceutical industry who require high-purity materials to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Losartan Potassium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity levels and assess drug product stability.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the US FDA, EMA, and PMDA.
• Pharmacopoeial Testing: Used to verify compliance with monographs in USP, EP, BP, and other international pharmacopoeias.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Losartan Impurity 7
CAS No.	358685-13-9
Molecular Formula	C22H23ClN6O
Molecular Weight	422.91 g/mol
Synonyms	Losartan Impurity G; Losartan Related Compound G; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol; 2-Butyl-4-chloro-1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-imidazole-5-methanol; EXP 3174 Impurity; Losartan Carboxylic Acid Impurity; BIBR 277 Impurity
EINECS	Contact for details

Quality Control

Our Losartan Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality standards align with ICH guidelines and support use in GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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