Description

Doxofylline Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Doxofylline, a key pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. Ensuring the integrity of your Doxofylline-based products starts with reliable reference materials like this impurity standard.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Doxofylline Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies of Doxofylline to monitor impurity formation over time and under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Doxofylline.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch testing to ensure Doxofylline meets stringent purity specifications.

Basic Information

Product Name	Doxofylline Impurity 1
CAS No.	1429636-74-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Doxofylline Related Compound 1; Doxofylline Impurity; 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethylpurine-2,6-dione Impurity 1; Doxofylline EP Impurity 1; Doxofylline USP Impurity 1; Doxofylline Process Impurity; Anhydrous Doxofylline Degradant
EINECS	Contact for details

Quality Control

Every batch of Doxofylline Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards (USP/EP). 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 a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Assay	90.0% - 110.0% (on anhydrous basis)

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