Description

Irinotecan Impurity 5 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Irinotecan Hydrochloride. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance with pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Irinotecan HCl API and its formulations.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels and ensure batches comply with strict regulatory specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in forced degradation and long-term stability studies of Irinotecan drug products.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Serves as a tool for investigating the chemical stability and degradation mechanisms of Irinotecan under various conditions.

Basic Information

Product Name	Irinotecan Impurity 5
CAS No.	2656-50-0
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; SN-38 Impurity; CPT-11 Impurity 5; Irinotecan Related Compound 5; 10-Hydroxy-7-ethylcamptothecin analog
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Impurity 5 is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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