Description

Domperidone Impurity 13 is a characterized impurity reference standard used in the analytical profiling and quality control of the antiemetic drug Domperidone. This high-purity compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It serves as an essential tool for method development, validation, and routine testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use 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: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity separation and detection.
• Quality Control & Assurance: Essential for routine batch release testing to verify that impurity levels are within the limits specified by pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in Domperidone under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Used in R&D laboratories to study the degradation pathways and impurity profile of Domperidone during synthesis and formulation processes.

Basic Information

Product Name	Domperidone Impurity 13
CAS No.	87120-77-2
Molecular Formula	C22H24ClN5O2
Molecular Weight	425.91 g/mol
Synonyms	1H-Benzimidazol-2-one, 5-chloro-1-[1-[3-(2,3-dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]-4-piperidinyl]-; Domperidone Related Compound; Domperidone EP Impurity C; Domperidone USP Related Compound; 5-Chloro-1-(1-(3-(2-oxobenzimidazolin-1-yl)propyl)piperidin-4-yl)benzimidazolin-2-one; Domperidone Impurity C; Domperidone Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Domperidone Impurity 13 is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Our quality protocols are designed to meet the stringent requirements of pharmaceutical impurity reference standard production. A comprehensive Certificate of Analysis (COA) detailing results from HPLC purity, NMR, and mass spectrometry confirmation is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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