Description

Domperidone Ep Impurity D is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the antiemetic drug Domperidone by enabling the accurate identification and quantification of related impurities. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Domperidone Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods, for impurity profiling.
• Quality Control and Batch Release: Employed in routine quality control testing to ensure Domperidone batches comply with specifications set by pharmacopeias like the European Pharmacopoeia (EP) and ICH guidelines.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to monitor the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., CMC sections of ANDA, NDA, MAA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Utilized in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity during the Domperidone synthesis process.

Basic Information

Product Name	Domperidone Ep Impurity D
CAS No.	1614255-34-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Domperidone Impurity D; Domperidone Related Compound D; Domperidone EP Impurity D; 5-Chloro-1-[1-[3-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one; Domperidone Impurity 4; Domperidone Specified Impurity D
EINECS	Contact for details

Quality Control

Our Domperidone Ep Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. 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 at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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