Description

Terazosin Impurity CAS NO 1260939-66-9 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Terazosin. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Terazosin API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Chemical Research & Synthesis: Used by research chemists to study the degradation pathways of Terazosin or to synthesize related compounds.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing in GMP environments.

Basic Information

Product Name	Terazosin Impurity
CAS No.	1260939-66-9
Molecular Formula	C₁₉H₂₅N₅O₄
Molecular Weight	387.44 g/mol
Synonyms	Terazosin Related Compound; Terazosin Degradant; 2-[4-[(2-Furanylcarbonyl)amino]-1-piperazinyl]-6,7-dimethoxy-4-quinazolinamine; 6,7-Dimethoxy-2-[4-[(2-furoyl)amino]-1-piperazinyl]-4-quinazolinamine; UNII-9N3X4F14F8; 9N3X4F14F8
EINECS	Contact for details

Quality Control

Our Terazosin Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Quality is assured through techniques including HPLC, NMR, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing all test results and confirming compliance with in-house specifications. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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