Description

2,2’-Bistetrazole-1,1’-Bisphenyl (Losartan Impurity) is a high-purity chemical reference standard and process impurity used in the development and quality control of active pharmaceutical ingredients (APIs). This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, validation, and regulatory compliance of Losartan and related sartan-class drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development, validation, and routine quality control testing of Losartan API.
• Process Chemistry R&D: Used to study and optimize synthetic pathways, helping to identify, control, and minimize the formation of this specific impurity during Losartan manufacturing.
• Regulatory Compliance & Filings: Essential for preparing impurity profiles and supporting documentation for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Stability Studies: Employed as a marker to monitor the degradation of Losartan under various stress conditions (e.g., heat, light, humidity) throughout its shelf life.
• Academic & Contract Research: Utilized in pharmacological and toxicological research to understand the impact of specific impurities on drug safety profiles.

Basic Information

Product Name	2,2’-Bistetrazole-1,1’-Bisphenyl (Losartan Impurity)
CAS No.	1159977-11-3
Molecular Formula	C14H10N8
Molecular Weight	290.28 g/mol
Synonyms	1,1'-Biphenyl-2,2'-diylbis(1H-tetrazole); Losartan Bistetrazole Impurity; Losartan Impurity; BTP; 2,2'-Bis(1H-tetrazol-1-yl)-1,1'-biphenyl; 1,1'-(1,1'-Biphenyl-2,2'-diyl)bis(1H-tetrazole); 2,2'-Bistetrazol-1-ylbiphenyl
EINECS	Contact for details

Quality Control

Every batch of 2,2’-Bistetrazole-1,1’-Bisphenyl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each shipment to support your GMP and regulatory requirements.

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 moisture-sensitive; keep the container tightly sealed in a desiccated area to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
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.