Description

Losartan Impurity 10 is a specified impurity and degradation product associated with the active pharmaceutical ingredient Losartan Potassium. This compound is critical for pharmaceutical research, development, and quality control, serving as a reference standard for analytical method validation and impurity profiling. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Losartan Potassium API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity analysis.
• Quality Control & Assurance: Employed in routine quality control testing to monitor impurity levels and ensure batches meet pharmacopeial specifications (USP, EP, ICH).
• Stability Studies: Used to track the formation of degradation products in Losartan formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate understanding and control of the impurity profile.
• Research & Development: Aids in synthetic route optimization and process chemistry studies to minimize impurity formation during API manufacturing.

Basic Information

Item	Detail
Product Name	Losartan Impurity 10
CAS No.	1350088-07-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Losartan Related Compound 10; Losartan Impurity J; Losartan EP Impurity J; Losartan USP Impurity; 2-Butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-methanol Impurity; 5-(4'-(4,5-Dihydro-2-butyl-4-chloro-1H-imidazol-1-ylmethyl)-[1,1'-biphenyl]-2-yl)-1H-tetrazole Impurity
EINECS	Contact for details

Quality Control

Our Losartan Impurity 10 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (IR, MS, NMR) to ensure identity, potency, and traceability. Certificates of Analysis (COA) with detailed chromatographic data are provided and comply with ICH Q3A/B and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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