Description

Domperidone Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic pharmaceutical, Domperidone. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) and its finished dosage forms. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Domperidone Impurity 15 in Domperidone API and drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurities during stability studies.
• Quality Control & Batch Release: Used in routine QC testing to ensure Domperidone batches comply with stringent pharmacopeial (e.g., USP, EP, ICH) limits for related substances.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data and specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity).
• Research & Development: Used in R&D to understand the degradation pathways and chemistry of Domperidone, aiding in process optimization.

Basic Information

Item	Detail
Product Name	Domperidone Impurity 15
CAS No.	142799-22-2
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 Related Compound B; Domperidone EP Impurity B; Domperidone USP Impurity; 1H-Benzimidazol-2-one, 5-chloro-1-[1-[3-(2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]-4-piperidinyl]-1,3-dihydro-
EINECS	Contact for details

Quality Control

Every batch of Domperidone Impurity 15 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of residual solvents and moisture. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. Our quality standards align with ICH guidelines and support compliance with cGMP, USP, and EP requirements.

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 anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.