Description

Losartan Impurity 2 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Losartan Potassium, a widely prescribed antihypertensive medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material 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 and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug product lifecycle.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Losartan products meet the strict impurity thresholds set by pharmacopeias (USP, EP, JP) and ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Research & Development: Utilized in synthetic chemistry R&D to understand and minimize the formation of this impurity during the Losartan manufacturing process.

Basic Information

Product Name	Losartan Impurity 2
CAS No.	1407521-00-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Losartan Related Compound 2; Losartan EP Impurity B; Losartan USP Impurity B; 2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol; 2-n-Butyl-4-chloro-5-(hydroxymethyl)-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]imidazole; EXP 3174 Impurity; BIBR 277 Impurity
EINECS	Contact for details

Quality Control

Our Losartan Impurity 2 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming identity, purity, and strength. Our quality standards are designed to support compliance with ICH Q3A, Q3B, USP, and EP requirements for pharmaceutical impurities.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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