Description

Irinotecan Impurity 3 is a specified impurity of the chemotherapeutic agent Irinotecan Hydrochloride, a critical component in pharmaceutical quality control and analytical research. This compound is essential for the development and validation of analytical methods to monitor and control impurity profiles in active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on oncology drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Irinotecan and related drug substances.
• Method Development and Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Impurity Profiling and Identification: Serves as an analytical marker to identify, characterize, and quantify this specific impurity in Irinotecan API batches to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and understand the degradation pathways of Irinotecan.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Research and Development: Used in synthetic chemistry R&D for route scouting and process optimization to minimize the formation of this impurity.

Basic Information

Product Name	Irinotecan Impurity 3
CAS No.	200619-21-2
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Impurity 3; (S)-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 Impurity 3; Irinotecan Related Compound 3
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH guidelines.

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 material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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