Description

Alfuzosin Impurity 1 CAS NO 19216-68-3 is a high-purity reference standard used for the identification and quantification of a specific process-related impurity in Alfuzosin hydrochloride, an active pharmaceutical ingredient (API). This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling precise analytical control during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Alfuzosin Impurity 1 in Alfuzosin API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the Alfuzosin API.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Pharmaceutical Research: Serves as a key intermediate or marker in synthetic route development and process optimization for Alfuzosin manufacturing.

Basic Information

Product Name	Alfuzosin Impurity 1
CAS No.	19216-68-3
Molecular Formula	C19H27N5O4
Molecular Weight	389.45 g/mol
Synonyms	Alfuzosin Related Compound A; 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(2-furanylcarbonyl)amino]piperidine; Alfuzosin EP Impurity A; Alfuzosin USP Impurity A; Alfuzosin Process Impurity; N-[4-Amino-6,7-dimethoxy-2-quinazolinyl]-N'-(2-furoyl)piperazine-1,4-diamine (alternative); Furoyl analog of Alfuzosin
EINECS	Contact for details

Quality Control

Every batch of Alfuzosin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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