Description

Irinotecan Impurity 29 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in Irinotecan Hydrochloride API and its drug products. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on oncology drug development and manufacturing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of a specific impurity in Irinotecan Hydrochloride Active Pharmaceutical Ingredient (API).
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity analysis in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine quality control testing of Irinotecan drug substances and finished products to ensure they meet stringent pharmacopeial (USP, EP, JP) specifications.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of Irinotecan formulations.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control and the safety profile of the drug product.
• Research & Development: Used in synthetic chemistry and process chemistry R&D to understand and mitigate the formation of this impurity during the manufacturing process.

Basic Information

Product Name	Irinotecan Impurity 29
CAS No.	797762-11-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Irinotecan Related Compound 29; Camptothecin-11 Impurity 29; (S)-4,11-Diethyl-4-hydroxy-9-[(4-piperidinopiperidino)carbonyloxy]-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione; Irinotecan Process Impurity; CPT-11 Impurity 29
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Impurity 29 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

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

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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.