Description

Terazosin Ep Impurity O CAS NO 547730-06-3 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the active pharmaceutical ingredient Terazosin. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of impurities during drug manufacturing. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories to ensure product safety and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Terazosin Ep Impurity O in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control and Release Testing: Essential for routine QC testing to ensure Terazosin API and formulations meet the impurity limits specified in pharmacopeias (e.g., USP, EP, ICH guidelines).
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile as per ICH Q3A/B requirements.
• Academic and Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and toxicological profile of Terazosin and its related substances.

Basic Information

Product Name	Terazosin Ep Impurity O
CAS No.	547730-06-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terazosin Related Compound O; Terazosin Impurity O; Terazosin EP Impurity O; 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]piperazine; UNII-4FQ5T2R5W2; 4FQ5T2R5W2; Terazosin European Pharmacopoeia Impurity O
EINECS	Contact for details

Quality Control

Every batch of Terazosin Ep Impurity O is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

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

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