Description

Dipyridamole Dichloro Dihydroxyethyl Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and analytical validation of Dipyridamole, an important antiplatelet medication. It is essential for laboratories requiring precise identification, quantification, and monitoring of this impurity to ensure drug safety and efficacy. This standard is primarily used by pharmaceutical manufacturers, analytical testing laboratories, and regulatory bodies focused on compliance and quality assurance.

Application

• Pharmaceutical Impurity Standard: Used as a certified reference material (CRM) for the identification and quantification of the Dichloro Dihydroxyethyl impurity in Dipyridamole active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods to ensure specificity, accuracy, and precision.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Dipyridamole, supporting ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and levels of this impurity during forced degradation and long-term stability studies of drug products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Dipyridamole Dichloro Dihydroxyethyl Impurity
CAS No.	1449029-15-5
Molecular Formula	C24H40Cl2N8O4
Molecular Weight	575.54 g/mol
Synonyms	Dipyridamole Impurity F; Dipyridamole Related Compound F; 2,2'-(2,2-Bis((2-hydroxyethyl)amino)-4,8-di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-6,4-diyl)bis(ethanol) dihydrochloride; 1,1'-(4,8-Di-1-piperidinylpyrimido[5,4-d]pyrimidine-2,6-diyl)bis(N-(2-hydroxyethyl)-N-(2-hydroxyethyl)amino)bis(2-chloroethane) dihydrochloride; Dipyridamole Dichloro Dihydroxyethyl Analog; Dipyridamole Process Impurity
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions suitable for pharmaceutical analysis. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. Our quality system ensures compliance with relevant guidelines, and a comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every unit.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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