Description

Domperidone Impurity E 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 pharmaceutical products containing Domperidone. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in method development and validation for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Domperidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels during drug development and manufacturing.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays, supporting compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Domperidone to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies such as the FDA, EMA, and other global health authorities.
• Research & Development: Used in academic and industrial R&D to study the metabolism, pharmacokinetics, and toxicological profile of Domperidone-related substances.

Basic Information

Product Name	Domperidone Impurity E
CAS No.	1346602-50-3
Molecular Formula	C22H24ClN5O2
Molecular Weight	425.91 g/mol
Synonyms	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 EP Impurity E; Domperidone Related Compound E; 1H-Benzimidazol-2-one, 5-chloro-1-[1-[3-(2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]-4-piperidinyl]-1,3-dihydro-; Domperidone Impurity 5; Domperidone Specified Impurity E
EINECS	Contact for details

Quality Control

Our Domperidone Impurity E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures reliable and consistent performance as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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