Description

Irinotecan Hydroxy Keto Impurity is a key process-related impurity and degradation product of the important chemotherapeutic agent Irinotecan HCl. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories and R&D teams in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs).

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Irinotecan HCl API and its drug products.
• Critical for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical quality control.
• Used in stability studies to monitor the degradation profile of Irinotecan under various stress conditions.
• Essential for regulatory submissions (e.g., ANDA, NDA) to establish impurity profiles and specifications.
• Supports process chemistry research to understand and control impurity formation during API synthesis.
• Employed in pharmacopoeial testing to comply with standards set by USP, EP, or other regulatory bodies.

Basic Information

Product Name	Irinotecan Hydroxy Keto Impurity
CAS No.	157770-58-6
Molecular Formula	C33H38N4O7
Molecular Weight	602.68 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; Irinotecan Related Compound H; SN-38 Impurity; CPT-11 Hydroxy Keto Impurity; 10-Hydroxycamptothecin derivative; Irinotecan Degradant
EINECS	Contact for details

Quality Control

Every batch of our Irinotecan Hydroxy Keto Impurity is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical characterization using advanced techniques like HPLC, LC-MS, and NMR to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification. Our quality commitment supports compliance with ICH Q3A/B guidelines and cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing desiccated at -20°C.

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)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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