Description

Terazosin Ep Impurity D is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of impurities during the manufacturing and stability testing of Terazosin hydrochloride, an α-blocker medication. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and third-party testing facilities. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments and validating testing methods.
• Method Development and Validation: Used in developing and qualifying HPLC, UPLC, and GC methods for impurity profiling.
• Quality Control and Batch Release: Critical for the comparative analysis of active pharmaceutical ingredient (API) and finished drug product batches against pharmacopeial limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Academic and Contract Research: Supports pharmacological and metabolic pathway research in academic institutions and CROs (Contract Research Organizations).

Basic Information

Product Name	Terazosin Ep Impurity D
CAS No.	84050-21-5
Molecular Formula	C₁₉H₂₅N₅O₄
Molecular Weight	387.44 g/mol
Synonyms	1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[[(tetrahydro-2-furanyl)carbonyl]amino]piperidine; Terazosin Related Compound D; Terazosin Impurity D; Terazosin EP Impurity D; Terazosin Hydrochloride Impurity D; 4-Amino-2-(4-((tetrahydrofuran-2-carbonyl)amino)piperidin-1-yl)-6,7-dimethoxyquinazoline; UNII-2J6J7A6Q2F
EINECS	Contact for details

Quality Control

Our Terazosin Ep Impurity D is manufactured and controlled under a strict quality management system. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH Q3A(R2) and Q3B(R2) guidelines for impurities. Our commitment ensures material suitability for its intended use in regulatory and compendial (EP/ USP) applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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