Description

Doxofylline Impurity 11 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Doxofylline. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable supply of this well-characterized impurity is essential for maintaining stringent pharmaceutical quality standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Doxofylline API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Doxofylline to understand its degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Utilized in synthetic chemistry research to study the formation, isolation, and characterization of process-related impurities.

Basic Information

Product Name	Doxofylline Impurity 11
CAS No.	109403-76-1
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 11; Doxofylline Impurity D; 1,3-Dimethyl-7-[(1,3-dioxolan-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione; Doxofylline EP Impurity D; Doxofylline USP Impurity; Doxofylline Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Doxofylline Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% 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.