Description

Alfuzosin EP Impurity C (N2-Methyl) HCl is a high-purity chemical reference standard, specifically the N2-methyl derivative of Alfuzosin hydrochloride. This compound is critically important for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research scientists, analytical chemists, and quality assurance professionals working in pharmaceutical development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for Alfuzosin HCl API and finished product testing.
• Analytical Method Development: Used to develop and optimize HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Critical for routine batch release testing to monitor and control impurity levels per ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to identify and quantify degradation products in forced degradation and long-term stability studies.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic route development and process optimization.

Basic Information

Product Name	Alfuzosin EP Impurity C (N2-Methyl) HCl
CAS No.	98902-34-2
Molecular Formula	C20H29N5O4 • HCl
Molecular Weight	440.94 g/mol
Synonyms	N2-Methylalfuzosin Hydrochloride; Alfuzosin N-Methyl Impurity; Alfuzosin Impurity C (EP); N-[3-[(4-Amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furancarboxamide, N-Methyl Derivative, Hydrochloride; Alfuzosin Related Compound C; 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(2-tetrahydrofuroyl)amino]piperidine, N-Methyl Derivative, HCl
EINECS	Contact for details

Quality Control

Every batch of Alfuzosin EP Impurity C (N2-Methyl) HCl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards (EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 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 single unknown 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.