Description

Losartan Impurity 12 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 compliance testing. Maintaining a reliable supply of this high-purity impurity standard is essential for upholding stringent Good Manufacturing Practice (GMP) standards in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Losartan Potassium active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Used in research and quality control laboratories to develop, optimize, and validate chromatographic methods, primarily HPLC and UPLC.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Losartan formulations under various stress conditions.
• Quality Control Testing: Used routinely in QC labs for the identification and quantification of this specific impurity to ensure batch-to-batch consistency and compliance with pharmacopeial limits.
• Pharmacopeial Testing: Supports testing as per United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other international pharmacopeia standards for Losartan.

Basic Information

Product Name	Losartan Impurity 12
CAS No.	727718-93-6
Molecular Formula	C22H23ClN6
Molecular Weight	406.91 g/mol
Synonyms	Losartan Related Compound 12; Losartan EP Impurity J; Losartan USP Impurity 12; 2-Butyl-5-chloro-3-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-3H-imidazo[4,5-b]pyridine; 2-Butyl-5-chloro-3-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-3H-imidazo[4,5-b]pyridine; 3-((2'-Carboxybiphenyl-4-yl)methyl)-2-butyl-5-chloro-3H-imidazo[4,5-b]pyridine Tetrazole Derivative
EINECS	Contact for details

Quality Control

Our Losartan Impurity 12 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. Our quality commitment supports your needs for regulatory filings and GMP-compliant operations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The container should be kept securely sealed in a cool, well-ventilated area away from incompatible materials.

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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.