Description

Terazosin Ep Impurity D CAS NO 102714-74-9 is a high-purity reference standard critical for analytical method development and validation in pharmaceutical quality control. This compound serves as a key specified impurity for the active pharmaceutical ingredient Terazosin, a medication used to treat hypertension and benign prostatic hyperplasia. It is essential for research and development laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments within the global pharmaceutical and contract research organization (CRO) sectors to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Terazosin Ep Impurity D in drug substances and finished products.
• Analytical Method Development and Validation: Serves as a critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Stability Studies and Forced Degradation Testing: Employed as a marker to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure impurity levels in Terazosin API and formulations remain within International Council for Harmonisation (ICH) and pharmacopoeial limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate thorough impurity characterization as per FDA, EMA, and other health authority requirements.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Terazosin to improve formulation stability and shelf-life.

Basic Information

Product Name	Terazosin Ep Impurity D
CAS No.	102714-74-9
Molecular Formula	C₁₉H₂₅N₅O₄
Molecular Weight	387.44 g/mol
Synonyms	1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[[(2S)-tetrahydro-2-furanyl]carbonyl]piperazine; Terazosin Impurity D; Terazosin Related Compound D; Terazosin EP Impurity D; Terazosin USP Impurity D; (S)-1-(4-Amino-6,7-dimethoxyquinazolin-2-yl)-4-(tetrahydrofuran-2-carbonyl)piperazine; Terazosin Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Terazosin Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, MS, NMR, and IR to ensure compliance with pharmacopoeial standards (e.g., USP, EP, BP, JP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The compound is light-sensitive (store away from light).

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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