Description

Doxofylline Impurity 4 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Doxofylline. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Doxofylline Impurity 4 in API batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Doxofylline API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Doxofylline Impurity 4
CAS No.	2095554-12-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Doxofylline Related Compound 4; Doxofylline EP Impurity D; Doxofylline Process Impurity; 7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethylpurine-2,6-dione Impurity; Doxofylline Specified Impurity; Doxofylline Degradant; Doxophylline Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Doxofylline Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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%
Assay	≥ 98.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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