Description

Losartan α-Butyl-Losartan Aldehyde Adduct (Losartan Impurity) is a designated impurity of the antihypertensive drug Losartan, identified by CAS number 1159977-48-6. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control in API manufacturing. It is essential for laboratories and manufacturers focused on ensuring the purity, safety, and regulatory compliance of Losartan-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Losartan Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug synthesis and stability studies.
• Quality Control & Assurance: Used in routine QC testing to ensure Losartan batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and dossiers.
• Process Chemistry Research: Aids in understanding the degradation pathways and formation mechanisms of impurities during Losartan synthesis, helping to optimize manufacturing processes.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to assess the shelf-life and storage conditions of Losartan products.

Basic Information

Product Name	Losartan α-Butyl-Losartan Aldehyde Adduct (Losartan Impurity)
CAS No.	1159977-48-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Losartan Aldehyde Adduct; Losartan Related Compound; Losartan Impurity A (Butyl Adduct); 2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxaldehyde adduct; Losartan Process Impurity; Losartan Degradant; Tetrazole aldehyde adduct of Losartan
EINECS	Contact for details

Quality Control

Our Losartan α-Butyl-Losartan Aldehyde Adduct is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity, ensuring it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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