Description

Doxofylline Impurity 7 CAS NO 43135-57-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Doxofylline. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Doxofylline API.
• Essential for pharmaceutical research and development (R&D) during process optimization and stability studies.
• Critical component in analytical method development and validation (HPLC, LC-MS) for quality control laboratories.
• Used for regulatory compliance and filing, supporting ICH guidelines for impurity characterization.
• Serves as a key material in pharmacopoeial testing to meet USP/EP monograph requirements.
• Supports academic and clinical research investigating the metabolism and degradation pathways of Doxofylline.

Basic Information

Product Name	Doxofylline Impurity 7
CAS No.	43135-57-5
Molecular Formula	C11H14N4O4
Molecular Weight	266.25 g/mol
Synonyms	1,3-Dimethyl-7-(2,3-dihydroxypropyl)-3,7-dihydro-1H-purine-2,6-dione; Doxofylline Related Compound; Doxofylline EP Impurity; Doxofylline USP Impurity; 7-(2,3-Dihydroxypropyl)theophylline; 1,3-Dimethyl-7-(2,3-dihydroxypropyl)xanthine
EINECS	Contact for details

Quality Control

Our Doxofylline Impurity 7 is manufactured under strict quality systems to ensure it meets the exacting standards for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B and relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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 degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (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.