Description

Dipyridamole Ep Impurity E is a specified impurity used in the quality control and analytical profiling of the antiplatelet drug Dipyridamole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug substance in compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is primarily required by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Dipyridamole Ep Impurity E in Dipyridamole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug development and manufacturing.
• Quality Control & Batch Release: Used in routine QC testing to ensure API batches meet the specified impurity limits as per EP, USP, or ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to health authorities like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Dipyridamole Ep Impurity E
CAS No.	2365420-11-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dipyridamole Impurity E; Dipyridamole Related Compound E; Dipyridamole EP Impurity E; 2,2',2'',2'''-(4,8-Di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,6-diyl)bis(azanetriyl)tetraethanol (proposed); Dipyridamole Degradation Product E; Dipyridamole Process Impurity E; Dipyridamole Specified Impurity E
EINECS	Contact for details

Quality Control

Every batch of Dipyridamole Ep Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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