Description

2'-(1H-Tetrazol-5-Yl)-1,1'-Biphenyl-4-Carboxaldehyde (Losartan Impurity) is a key chemical reference standard used in the pharmaceutical development and quality control of Losartan potassium, an angiotensin II receptor antagonist. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by identifying and quantifying related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Losartan potassium API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Losartan products meet pharmacopeial specifications (USP, EP, JP).
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to monitor the formation of degradation products in Losartan under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Used in synthetic chemistry research to study the degradation pathways and metabolism of Losartan.

Basic Information

Product Name	2'-(1H-Tetrazol-5-Yl)-1,1'-Biphenyl-4-Carboxaldehyde (Losartan Impurity)
CAS No.	151052-40-3
Molecular Formula	C15H10N4O
Molecular Weight	262.27 g/mol
Synonyms	Losartan Aldehyde Impurity; Losartan Related Compound A; 4'-(Formyl)-2-cyanobiphenyl-4-yl tetrazole; 2-Cyano-4'-(formyl)biphenyl-4-yl tetrazole; Biphenyl-4-carboxaldehyde, 2'-(1H-tetrazol-5-yl)-; 5-(4'-Formylbiphenyl-2-yl)-1H-tetrazole; Losartan Impurity A; Losartan Aldehyde
EINECS	Contact for details

Quality Control

Our 2'-(1H-Tetrazol-5-Yl)-1,1'-Biphenyl-4-Carboxaldehyde is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results and traceability is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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