Description

Dipyridamole Impurity I is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antiplatelet drug Dipyridamole by enabling the accurate identification and quantification of related impurities. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Dipyridamole.
• Method Development and Validation: Critical for developing and validating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control and Batch Release: Used in the routine testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor impurity profiles.
• Stability Studies: Employed to track the formation of degradation products in Dipyridamole formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Pharmacopoeial Testing: Supports testing to meet the stringent impurity limits specified in pharmacopoeias like USP, EP, and BP.

Basic Information

Product Name	Dipyridamole Impurity I
CAS No.	2188148-58-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dipyridamole Related Compound I; Dipyridamole Impurity 1; Dipyridamole EP Impurity I; Dipyridamole USP Impurity I; 2,2',2'',2'''-(4,8-Di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,6-diyl)bis(azanetriyl)tetraethanol (related impurity); Persantine Impurity I
EINECS	Contact for details

Quality Control

Every batch of Dipyridamole Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP, ICH Q3A/B, and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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