Description

Doxazosin Acetylpiperazinyl Impurity (CAS No. 695217-74-4) is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of Doxazosin, an α-blocker medication used to treat hypertension and benign prostatic hyperplasia. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require precise standards for method development, validation, and regulatory compliance. Utilizing this impurity ensures the safety, efficacy, and purity of the final active pharmaceutical ingredient.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Doxazosin Mesylate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor and control process-related impurities.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and finished product formulators to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data for Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Stability Studies: Employed as a marker to track impurity profiles in stability testing of Doxazosin formulations under various storage conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway for Doxazosin to minimize the formation of this specific impurity.

Basic Information

Product Name	Doxazosin Acetylpiperazinyl Impurity
CAS No.	695217-74-4
Molecular Formula	C23H25N5O5
Molecular Weight	451.48 g/mol
Synonyms	1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(2,3-dihydro-1,4-benzodioxin-2-yl)carbonyl]piperazine; Doxazosin EP Impurity F; Doxazosin Impurity F; Doxazosin Related Compound F; Doxazosin Acetyl Piperazine Impurity; (2,3-Dihydro-1,4-benzodioxin-2-yl)-[4-(6,7-dimethoxy-2-quinazolinyl)-1-piperazinyl]methanone; UNII-0D9W8V8G4F
EINECS	Contact for details

Quality Control

Our Doxazosin Acetylpiperazinyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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