Description

Doxazosin Impurity CAS NO 1219803-95-8 is a high-purity chemical reference standard used for the identification, qualification, and quantification of related substances in Doxazosin Mesylate active pharmaceutical ingredient (API) and finished drug products. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and biotechnology industries for method development and validation.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying this specific impurity in Doxazosin Mesylate batches.
• Analytical Method Development & Validation: Used as a standard to develop, calibrate, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine testing in pharmaceutical QC labs to ensure API and drug products meet ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA, EMA, and others to demonstrate control over the manufacturing process.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) as per ICH stability guidelines.
• Research & Development: Used in pharmaceutical R&D to study degradation pathways and to synthesize purer forms of the active ingredient.

Basic Information

Product Name	Doxazosin Impurity
CAS No.	1219803-95-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Doxazosin Related Compound; Doxazosin Mesylate Impurity; Doxazosin Process Impurity; Doxazosin Degradant; 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-((2,3-dihydro-1,4-benzodioxin-2-yl)carbonyl)piperazine Impurity; Doxazosin Specified Impurity; Doxazosin Unknown Impurity (as per specific batch); Benzodioxanyl Carbonyl Doxazosin Analog
EINECS	Contact for details

Quality Control

Every batch of Doxazosin Impurity (CAS 1219803-95-8) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 must be kept under inert atmosphere or in a desiccator to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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