Description

Terazosin Impurity J is a high-purity chemical reference standard used in the analytical profiling of the antihypertensive drug Terazosin. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of related substances to ensure drug safety and efficacy. It is an essential material for quality control laboratories in the pharmaceutical industry, regulatory agencies, and academic institutions focused on analytical method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Terazosin and its related products.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (HPLC, UPLC) for impurity profiling in compliance with ICH guidelines.
• Quality Control & Assurance: Serves as a system suitability and identification standard in the routine QC testing of Terazosin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to monitor the formation of degradation products in Terazosin formulations under various stress conditions.
• Research & Development: Facilitates synthetic route optimization and process chemistry studies by tracking specific impurity formation.

Basic Information

Product Name	Terazosin Impurity J
CAS No.	152551-75-2
Molecular Formula	C₁₉H₂₅N₅O₄
Molecular Weight	387.44 g/mol
Synonyms	1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[[(2RS)-tetrahydro-2-furanyl]carbonyl]piperazine; Terazosin Related Compound J; Terazosin EP Impurity J; Terazosin USP Impurity J; Terazosin Process Impurity; (RS)-1-(4-Amino-6,7-dimethoxyquinazolin-2-yl)-4-(tetrahydrofuran-2-carbonyl)piperazine
EINECS	Contact for details

Quality Control

Every batch of Terazosin Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (USP, EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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