Description

Terazosin Ep Impurity I is a high-purity reference standard used in the analytical development and quality control of the active pharmaceutical ingredient Terazosin. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by accurately identifying and quantifying related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) focused on cardiovascular drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Terazosin API and finished dosage forms.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (HPLC, UPLC) for the precise separation and detection of Terazosin and its related substances.
• Stability Studies: Employed to monitor the formation of degradation products in Terazosin formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Contract Laboratory Analysis: A key reagent for third-party testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Terazosin Ep Impurity I
CAS No.	1799288-88-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terazosin Impurity I; Terazosin Related Compound I; Terazosin EP Impurity I; 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]piperazine; Terazosin Process Impurity; Terazosin Degradant; Terazosin Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Terazosin Ep Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

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 (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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