Description

Doxofylline Impurity 8 is a specified impurity of the bronchodilator drug Doxofylline, identified by the CAS number 123524-29-8. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this impurity during drug substance manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting method validation, stability studies, and regulatory compliance for Doxofylline API production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Doxofylline.
• Analytical Method Development and Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control and Assurance: Serves as a system suitability standard and for setting impurity acceptance criteria in drug substance specifications.
• Stability Studies: Employed to monitor the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Pharmacopoeial Testing: Supports testing to meet the requirements of pharmacopoeias such as USP, EP, or JP for Doxofylline monographs.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and develop purer synthesis routes.

Basic Information

Product Name	Doxofylline Impurity 8
CAS No.	123524-29-8
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 8; Doxofylline EP Impurity H; Doxofylline USP Impurity; 1,3-Dimethyl-7-[(1,3-dioxolan-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione; Doxofylline Process Impurity; Doxofylline Degradant
EINECS	Contact for details

Quality Control

Every batch of Doxofylline Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling 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 lot, detailing 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 at controlled room temperature (15-25°C) or as indicated on the label. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on dried basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 2.0%

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