Description

2,2',2'',2'''-[[4-[(2-Hydroxyethyl)Amino]-8-(1-Piperidinyl)Pyrimido[5,4-D]Pyrimidine-2,6-Diyl]Dinitrilo]Tetrakisethanol (Dipyridamole Impurity) is a critical process-related impurity and reference standard used in the development and quality control of the pharmaceutical agent Dipyridamole. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in API synthesis, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of this specific impurity in Dipyridamole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and release testing.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Critical for routine quality control testing to ensure API batches comply with stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate control over the manufacturing process and product quality.
• Process Chemistry Research: Used by R&D scientists to study and optimize the synthetic pathway of Dipyridamole, aiming to minimize the formation of this impurity.

Basic Information

Product Name	2,2',2'',2'''-[[4-[(2-Hydroxyethyl)Amino]-8-(1-Piperidinyl)Pyrimido[5,4-D]Pyrimidine-2,6-Diyl]Dinitrilo]Tetrakisethanol (Dipyridamole Impurity)
CAS No.	60286-30-8
Molecular Formula	C27H42N10O6
Molecular Weight	602.70 g/mol
Synonyms	Dipyridamole Impurity; Dipyridamole Related Compound; 2,2',2'',2'''-[[4-[(2-Hydroxyethyl)amino]-8-(1-piperidinyl)pyrimido[5,4-d]pyrimidine-2,6-diyl]dinitrilo]tetrakis-Ethanol; Tetrakis(2-hydroxyethyl) derivative of Dipyridamole intermediate; Persantine Impurity
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including advanced techniques like HPLC and LC-MS, to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the exact specifications and test results. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference standards.

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); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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