Description

Doxofylline Impurity 7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity in Doxofylline active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for analytical laboratories, R&D facilities, and manufacturers engaged in the development, validation, and routine testing of Doxofylline-based medications to ensure product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Quality Control & Assurance: For the identification and quantification of Impurity 7 in Doxofylline API batches to meet pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Supporting regulatory submissions (e.g., FDA, EMA) by providing characterized impurity samples for stability and toxicology studies.
• Research & Development: Used in studies to understand the formation, degradation pathways, and control of this impurity during API synthesis.
• Analytical Laboratory Calibration: Serves as a system suitability standard in HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Testing: Employed as a marker to track impurity levels in stability studies of Doxofylline formulations.

Basic Information

Product Name	Doxofylline Impurity 7
CAS No.	1429636-73-6
Molecular Formula	C11H14N4O4
Molecular Weight	266.25 g/mol
Synonyms	7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione; Doxofylline Related Compound 7; Doxofylline EP Impurity G; 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 7 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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