Description

Irinotecan Impurity 24 is a specified impurity of the chemotherapeutic agent Irinotecan Hydrochloride, a critical component in the treatment of colorectal and other cancers. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and quality control departments to ensure the purity, safety, and efficacy of Irinotecan-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Irinotecan Hydrochloride Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Irinotecan and to establish appropriate storage conditions and shelf-life for drug formulations.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure that impurity levels in commercial batches remain within specified safety limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing authorization applications.
• Process Chemistry Research: Used in research to optimize synthesis and purification processes for Irinotecan, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Irinotecan Impurity 24
CAS No.	802277-44-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Irinotecan Related Compound 24; Irinotecan Impurity D (Potential); 7-Ethyl-10-hydroxycamptothecin Impurity; CPT-11 Impurity 24; (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; SN-38 Impurity (related); Camptothecin analog impurity
EINECS	Contact for details

Quality Control

Our Irinotecan Impurity 24 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, test methods, and results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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