Description

[1,1'-Biphenyl]-2’-Tetrazolo-4-Carboxylic Acid, [1,1'-Biphenyl]-2’Tetrazolo-4-Ylmethyl Ester is a designated impurity of the widely prescribed antihypertensive drug Losartan. This compound is critical for pharmaceutical research and development, specifically for analytical method validation and quality control processes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and regulatory testing laboratories to ensure drug purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used 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 & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and LC-MS methods to monitor impurity profiles 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 assess the stability and shelf-life of Losartan-based drug products.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data required for drug master files (DMFs) and marketing authorization applications.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during Losartan synthesis, enabling process optimization and impurity control strategies.

Basic Information

Product Name	[1,1'-Biphenyl]-2’-Tetrazolo-4-Carboxylic Acid, [1,1'-Biphenyl]-2’Tetrazolo-4-Ylmethyl Ester (Losartan Impurity)
CAS No.	1159977-10-2
Molecular Formula	C21H16N4O2
Molecular Weight	356.38 g/mol
Synonyms	Losartan Impurity; Losartan Related Compound; 2'-(2H-Tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl 2-(2H-tetrazol-5-yl)benzoate; Biphenyl Tetrazole Methyl Ester; 5-((2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-tetrazole-1-acetic Acid; Losartan Tetrazole Impurity; 1159977-10-2; Cozaar Impurity
EINECS	Contact for details

Quality Control

This high-purity impurity standard is manufactured under controlled GMP-like conditions to ensure batch-to-batch consistency and traceability. Quality is verified through a comprehensive suite of analytical techniques including HPLC (for purity and assay), LC-MS, 1H-NMR, and 13C-NMR for structural confirmation. A detailed Certificate of Analysis (CoA) is provided with each batch, documenting purity, identity, and impurity profile. Our quality system is designed to meet the exacting requirements of pharmaceutical R&D and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

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)	≥ 95.0%
Assay (HPLC)	≥ 97.0%
Related Substances (HPLC)	Total impurities ≤ 3.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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