Description

Irinotecan Furan Ring Impurity is a specified impurity of the potent chemotherapeutic agent Irinotecan HCl, identified by CAS No. 143490-54-4. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical method development and validation required for drug substance quality control. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Irinotecan-based drug products by accurately monitoring and controlling this specific degradant.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the furan ring impurity in Irinotecan HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating high-performance liquid chromatography (HPLC) and other chromatographic methods to separate and detect this specific impurity.
• Quality Control & Assurance: Employed in routine QC testing of Irinotecan batches to ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3A/B, USP, EP) for related substances.
• Stability Studies: Used to monitor the formation of this degradant over time under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Aids in understanding the degradation pathways of Irinotecan during API synthesis, formulation, and storage to develop robust manufacturing processes.

Basic Information

Product Name	Irinotecan Furan Ring Impurity
CAS No.	143490-54-4
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	Irinotecan Impurity F; Irinotecan Furan Impurity; (4S)-4,11-Diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-9-yl [1,4'-bipiperidine]-1'-carboxylate; CPT-11 Furan Ring Degradant; 7-ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Furan Impurity; SN-38 Furan Ring Related Compound
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Furan Ring Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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