Description

Domperidone Ep Impurity F is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical agent Domperidone. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily used by quality assurance and R&D professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of Domperidone drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Domperidone API and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Domperidone.
• Research & Development: Used in academic and industrial R&D for studying the degradation pathways and metabolism of Domperidone.

Basic Information

Product Name	Domperidone Ep Impurity F
CAS No.	1391053-55-6
Molecular Formula	C22H24ClN5O2
Molecular Weight	425.91 g/mol
Synonyms	Domperidone Impurity F; Domperidone Related Compound F; 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; 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 F
EINECS	Contact for details

Quality Control

Our Domperidone Ep Impurity F is manufactured under strict quality control conditions to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is thoroughly characterized using advanced analytical techniques, including HPLC, GC, MS, and NMR, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical data, supporting compliance with EP, USP, and ICH Q3B guidelines.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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 unknown impurity: ≤ 0.10% 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.