Description

Terazosin Dimer Impurity Dihcl is a high-purity reference standard and pharmaceutical impurity used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antihypertensive drug Terazosin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of the dimer impurity in Terazosin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels remain within specified safety limits.
• Stability Studies: Employed to track the formation of degradation products in Terazosin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to regulatory agencies like the FDA and EMA.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the behavior and impact of this specific impurity.

Basic Information

Product Name	Terazosin Dimer Impurity Dihcl
CAS No.	1486464-41-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Terazosin Dimer Impurity; Terazosin Dimer; Terazosin Related Compound D; Terazosin Impurity D; 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[[(2RS)-tetrahydro-2-furanyl]carbonyl]piperazine Dihydrochloride Dimer; Terazosin Dimer Dihydrochloride; Terazosin Dimer HCl
EINECS	Contact for details

Quality Control

Our Terazosin Dimer Impurity Dihcl is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC, LC-MS, and NMR. We adhere to relevant ICH and pharmacopeial guidelines to support your regulatory and compliance needs.

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 compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.