Description

Domperidone Ep Impurity B is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Domperidone, a widely used antiemetic and prokinetic agent. 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) to identify, quantify, and control this specific impurity in Domperidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of Domperidone batches to monitor impurity levels against pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Used to track the formation of this impurity during forced degradation and long-term stability studies of Domperidone products.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Utilized in R&D laboratories for studying the degradation pathways and chemical behavior of Domperidone.

Basic Information

Product Name	Domperidone Ep Impurity B
CAS No.	1346598-11-5
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 Impurity B (EP); Domperidone Related Compound B; 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 EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Domperidone Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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