Description

Urapidil Impurity 20 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antihypertensive drug Urapidil. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in research, method validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining batch-to-batch consistency.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Urapidil Impurity 20 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product specifications are met.
• Regulatory Compliance & Filings: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used as a marker to track the formation of degradation products in Urapidil formulations under various stress conditions.
• Research & Development (R&D): Facilitates the study of impurity formation pathways, synthesis processes, and purification strategies for Urapidil.

Basic Information

Product Name	Urapidil Impurity 20
CAS No.	41949-07-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-({3-[4-(2-Methoxyphenyl)piperazin-1-yl]propyl}amino)-1,3-dimethylpyrimidine-2,4(1H,3H)-dione; Urapidil Related Compound; Urapidil Process Impurity; Urapidil Degradant; 1,3-Dimethyl-6-({3-[4-(o-methoxyphenyl)-1-piperazinyl]propyl}amino)-2,4(1H,3H)-pyrimidinedione
EINECS	Contact for details

Quality Control

Every batch of Urapidil Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for parameters such as assay, related substances, and residual solvents.

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 conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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