Description

Irinotecan Impurity 18 is a high-purity chemical reference standard used for the analytical profiling and control of the active pharmaceutical ingredient, Irinotecan Hydrochloride. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Irinotecan HCl API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity detection and separation.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity identity and characterization data for health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Irinotecan to minimize the formation of this specific impurity.
• Pharmacopoeial Testing: Used for testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify impurity limits for Irinotecan.

Basic Information

Product Name	Irinotecan Impurity 18
CAS No.	1255644-71-3
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	(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-carboxylic acid; 7-Ethyl-10-hydroxycamptothecin Impurity; CPT-11 Impurity 18; SN-38 Impurity related compound; Irinotecan Related Compound 18; (19S)-10,19-Dihydroxy-7-ethyl-19-oxocamptothecin
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Impurity 18 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The material is light-sensitive (store away from light).

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%
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.