Description

Dipyridamole Trichloro Impurity is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient Dipyridamole by accurately identifying and quantifying related process impurities. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in method validation, stability studies, and regulatory compliance. The availability of this well-characterized impurity standard is essential for meeting stringent global pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify the trichloro impurity in Dipyridamole drug substance and finished products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines in commercial batches.
• Stability Studies and Forced Degradation Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Essential for preparing documentation for regulatory agencies (FDA, EMA, etc.) to demonstrate control over the manufacturing process and product quality.
• Research and Development (R&D): Utilized in synthetic chemistry R&D to understand and optimize the Dipyridamole synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Dipyridamole Trichloro Impurity
CAS No.	1449029-14-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2,2',2''-[(4,8-Di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,6-diyl)bis(azanetriyl)]triethanol Trichloro Derivative; Dipyridamole Related Compound C (Trichloro); Dipyridamole Process Impurity; 2,6-Bis(di(2-hydroxyethyl)amino)-4,8-dipiperidinopyrimido[5,4-d]pyrimidine Trichloro Impurity
EINECS	Contact for details

Quality Control

Our Dipyridamole Trichloro Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data (HPLC/LC-MS) for traceability and compliance. The quality standards are aligned with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The container should be kept tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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