Description

Urapidil Impurity 45 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 for the identification and quantification of impurities in Urapidil drug substances and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Urapidil formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Urapidil.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing of Urapidil API.

Basic Information

Item	Details
Product Name	Urapidil Impurity 45
CAS No.	3197-14-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Urapidil Related Compound 45; Urapidil Impurity F; 6-({3-[4-(2-Methoxyphenyl)piperazin-1-yl]propyl}amino)-1,3-dimethylpyrimidine-2,4(1H,3H)-dione; 1,3-Dimethyl-6-({3-[4-(2-methoxyphenyl)-1-piperazinyl]propyl}amino)-2,4(1H,3H)-pyrimidinedione; Urapidil EP Impurity F; Urapidil USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Urapidil Impurity 45 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS, IR) techniques to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
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
Water Content (KF)	≤ 5.0%

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