Description

Doxofylline Impurity CAS NO 254760-82-2 is a high-purity reference standard used for the identification, qualification, and quantification of related substances in Doxofylline active pharmaceutical ingredient (API) and finished drug products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by enabling precise analytical control. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC/QA protocols.
• Impurity Profiling and Identification: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify specific process-related or degradation impurities in Doxofylline API.
• Method Development and Validation: Essential for developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies in line with ICH Q3A/B.
• Stability Studies: Employed to monitor impurity formation in Doxofylline formulations under various stress conditions (heat, light, humidity).
• Research and Development: Utilized in pharmaceutical R&D to study degradation pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Item	Details
Product Name	Doxofylline Impurity
CAS No.	254760-82-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Doxofylline Related Compound; Doxofylline Impurity Standard; 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethylpurine-2,6-dione impurity; Doxofylline EP Impurity; Doxofylline USP Impurity; Doxofylline Process Impurity; Doxofylline Degradant
EINECS	Contact for details

Quality Control

Every batch of Doxofylline Impurity CAS 254760-82-2 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC, GC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with pharmacopeial standards. Our quality commitment ensures reliability for your critical analytical and regulatory applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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