Description

Irinotecan Impurity 11 is a specified impurity and degradation product of the important chemotherapeutic agent Irinotecan HCl. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Irinotecan API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Irinotecan HCl Active Pharmaceutical Ingredient (API).
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Stability Studies & Forced Degradation: Used to monitor and understand the degradation pathways of Irinotecan under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity profiles and meeting ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.
• Pharmaceutical R&D: Aids in the research of impurity formation mechanisms and the synthesis of purer Irinotecan batches.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure every batch of Irinotecan API meets stringent purity specifications.

Basic Information

Product Name	Irinotecan Impurity 11
CAS No.	124622-81-7
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	(4S)-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; 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Impurity; CPT-11 Impurity 11; Irinotecan Related Compound 11; SN-38 10-O-glucuronide aglycone derivative
EINECS	Contact for details

Quality Control

Our Irinotecan Impurity 11 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each lot undergoes comprehensive analytical characterization using techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile. Our quality commitment aligns with the standards expected for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Single Unknown Impurity	≤ 1.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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