Description

Irinotecan Impurity 8 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 manufacturers and analytical laboratories engaged in the development, quality control, and regulatory compliance of Irinotecan drug substances and products. Its primary value lies in serving as a certified reference standard for method validation, stability studies, and impurity profiling, ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Irinotecan Impurity 8 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of Irinotecan to understand degradation pathways and establish shelf-life.
• Quality Control & Batch Release: Essential for routine QC testing in pharmaceutical manufacturing to ensure every batch meets stringent purity specifications.
• 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 applications.
• Research & Development: Used in R&D laboratories for studying the metabolism, pharmacokinetics, and toxicological profile of Irinotecan-related substances.

Basic Information

Item	Detail
Product Name	Irinotecan Impurity 8
CAS No.	936348-90-2
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Impurity 8; (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; Irinotecan Related Compound 8; Camptothecin-11, 7-ethyl-10-[4-(1-piperidinyl)-1-piperidinyl]carbonyloxy-, (S)-, impurity; UNII-9V8V3E8A6B
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Impurity 8 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using advanced chromatographic and spectroscopic techniques to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, and other critical parameters. Our quality standards are designed to support compliance with ICH Q3A, Q3B, and pharmacopeial guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	90.0% - 110.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual 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.