Description

Urapidil Impurity 7 CAS NO 108997-11-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antihypertensive active pharmaceutical ingredient (API) Urapidil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Urapidil drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing in pharmaceutical manufacturing to ensure batches meet pharmacopeial (e.g., USP, EP) specifications for impurity limits.
• Stability Studies: Employed in forced degradation and long-term stability studies of Urapidil to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in R&D laboratories to study the degradation pathways, synthesis by-products, and metabolism of Urapidil.

Basic Information

Product Name	Urapidil Impurity 7
CAS No.	108997-11-1
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 Degradant; Urapidil Process Impurity; 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 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC and MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The original container should be sealed tightly after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.