Description

Doxofylline Impurity 6 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 active ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. Ensuring the identity and purity of this impurity is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Doxofylline Impurity 6 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development and validation to establish accurate detection limits and calibration curves.
• Quality Control & Assurance: Essential for routine quality control testing in pharmaceutical manufacturing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• 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: Utilized in academic and industrial R&D for studying the degradation pathways, metabolism, and synthesis of Doxofylline-related compounds.

Basic Information

Product Name	Doxofylline Impurity 6
CAS No.	1429636-72-5
Molecular Formula	C11H14N4O4
Molecular Weight	266.25 g/mol
Synonyms	7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethylpurine-2,6-dione; Doxofylline Related Compound 6; Doxofylline EP Impurity F; Doxofylline USP Impurity; 1,3-Dimethyl-7-[(1,3-dioxolan-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione
EINECS	Contact for details

Quality Control

Every batch of Doxofylline Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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