Description

Irinotecan Impurity 19 is a high-purity reference standard used in the pharmaceutical development and quality control of the anticancer drug Irinotecan HCl. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific impurity in Irinotecan HCl active pharmaceutical ingredient (API) and finished drug products.
• Quality Control (QC) Testing: Routine use in QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation and level of impurities during drug product stability testing under various conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control.
• Research and Development: Aids in process chemistry optimization to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Irinotecan Impurity 19
CAS No.	142706-06-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Impurity; CPT-11 Impurity 19; (S)-4,11-Diethyl-4-hydroxy-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate; Irinotecan Related Compound 19; SN-38 10-O-carboxylate piperidinopiperidine amide impurity
EINECS	Contact for details

Quality Control

Our Irinotecan Impurity 19 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white 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 unknown 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.