Description

Pentoxifylline Impurity I is a specified impurity and reference standard used in the quality control and analytical profiling of the pharmaceutical active ingredient Pentoxifylline. This compound is critical for ensuring the purity, safety, and efficacy of Pentoxifylline drug substances and finished products through rigorous chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine quality assurance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Pentoxifylline Impurity I in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Pentoxifylline batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Pentoxifylline meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profile data for health authorities like the FDA and EMA.
• Research & Development (R&D): Utilized in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Pentoxifylline.

Basic Information

Product Name	Pentoxifylline Impurity I
CAS No.	55247-90-0
Molecular Formula	C13H18N4O3
Molecular Weight	278.31 g/mol
Synonyms	1-(5-Oxohexyl)-3,7-dimethylxanthine; 3,7-Dimethyl-1-(5-oxohexyl)-3,7-dihydro-1H-purine-2,6-dione; 1-(5-Oxohexyl)theobromine; Pentoxifylline Related Compound I; Oxpentifylline Impurity I; Trental Impurity I; BL 191 Impurity I
EINECS	Contact for details

Quality Control

Our Pentoxifylline Impurity I is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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