Description

Pentoxifylline Impurity CAS NO 1243654-85-4 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 Pentoxifylline, a pharmaceutical active ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard to identify, quantify, and monitor this specific impurity in Pentoxifylline Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine quality control testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and purity.
• Stability Studies: Employed in forced degradation and long-term stability studies of Pentoxifylline to understand degradation pathways and establish shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA) to regulatory agencies like the US FDA and EMA.
• Research & Development: Used in academic and industrial R&D settings for studying the metabolism, pharmacokinetics, and toxicological profile of Pentoxifylline-related compounds.

Basic Information

Product Name	Pentoxifylline Impurity
CAS No.	1243654-85-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pentoxifylline Related Compound, Pentoxifylline Process Impurity, 1-(5-Oxohexyl)-3,7-dimethylxanthine Impurity, 3,7-Dimethyl-1-(5-oxohexyl)-3,7-dihydro-1H-purine-2,6-dione Related Substance, Oxpentifylline Impurity, Trental Impurity
EINECS	Contact for details

Quality Control

Our Pentoxifylline Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to ensure traceability and compliance with pharmaceutical reference standard requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.