Description

Pentoxifylline Impurity 8 (Pentoxifylline EP Impurity H) is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of the active pharmaceutical ingredient Pentoxifylline. It is primarily required by professionals in pharmaceutical development, quality assurance, and regulatory compliance for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Pentoxifylline EP Impurity H in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or GC analytical methods in quality control laboratories.
• Impurity Profiling & Characterization: Supports studies to identify, monitor, and control impurities as per ICH Q3A(R2) and Q3B(R2) guidelines for drug substance and product qualification.
• Stability Studies: Employed in forced degradation and long-term stability testing to track impurity formation and ensure product shelf-life.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions to agencies like the US FDA, EMA, and other global health authorities.
• Pharmacopoeial Testing: Used in testing to comply with pharmacopoeial monographs, including the European Pharmacopoeia (EP) and United States Pharmacopeia (USP).
• Research & Development: Serves as a key reagent in synthetic chemistry research and the development of impurity synthesis pathways.

Basic Information

Product Name	Pentoxifylline Impurity 8 (Pentoxifylline EP Impurity H)
CAS No.	200556-62-3
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; Pentoxifylline Related Compound H; Pentoxifylline Impurity H; Pentoxifylline EP Impurity H; 1H-Purine-2,6-dione, 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-; Pentoxifylline Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pentoxifylline Impurity 8 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopoeial and industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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