Description

Losartan Isomer Impurity, Potassium Salt is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Losartan potassium, a widely prescribed antihypertensive medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug substance and drug product manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific isomeric impurities in Losartan potassium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to accurately separate and measure impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity profiles, ensuring compliance with pharmacopeial specifications (USP, EP, ICH).
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research & Development: Serves as a key reagent in synthetic chemistry research for studying degradation pathways and developing improved synthetic processes for Losartan.

Basic Information

Product Name	Losartan Isomer Impurity, Potassium Salt
CAS No.	860644-28-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Losartan Related Compound; Losartan Isomer Potassium; Losartan Impurity; (2-Butyl-4-chloro-1-{[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}-1H-imidazol-5-yl)methanol, Potassium Salt (Isomer); Losartan Potassium Isomeric Impurity; BP Impurity of Losartan Potassium; Angiotensin II Receptor Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Losartan Isomer Impurity, Potassium Salt is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results for purity, assay, and related substances. Our quality commitment aligns with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	Contact for details
Water Content (KF)	Contact for details
Residual Solvents (GC)	Complies with ICH limits

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