Description

Losartan Impurity 16 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 batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines from the USP, EP, and ICH.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Losartan Potassium Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies and forced degradation studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Losartan batches meet the strict impurity thresholds set by ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data and specifications.
• Stability Studies: Used to track the formation and growth of this impurity over time under various storage conditions, supporting shelf-life determination.
• Research & Development: Aids in process chemistry research to understand and minimize the formation of this impurity during the synthesis of Losartan.

Basic Information

Product Name	Losartan Impurity 16
CAS No.	212316-86-4
Molecular Formula	C22H23ClN6
Molecular Weight	406.91 g/mol
Synonyms	Losartan Related Compound H; Losartan EP Impurity H; Losartan USP Impurity 16; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol; 2-Butyl-4-chloro-1-((2'-(1H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-1H-imidazole-5-methanol; Losartan Alcohol Impurity; EXP 3175 Alcohol; Losartan Carbinol
EINECS	Contact for details

Quality Control

Our Losartan Impurity 16 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 lot, detailing the results against relevant pharmacopeial (USP, EP) and ICH specifications. We are committed to supply chain reliability and full traceability for all our reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent degradation.

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 individual unspecified impurity ≤ 0.5%
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.