Description

Irinotecan Lactone Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the anticancer drug Irinotecan HCl. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material for the identification and quantification of the lactone form impurity in Irinotecan HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing and validating high-performance liquid chromatography (HPLC) and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure drug substance and product purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Utilized in preclinical and clinical research to understand the pharmacokinetics, metabolism, and toxicity profile of Irinotecan-related compounds.

Basic Information

Product Name	Irinotecan Lactone Impurity
CAS No.	143490-53-3
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	(S)-4,11-Diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate; Irinotecan Lactone Form; CPT-11 Lactone; 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Lactone; Camptothecin-11 Lactone Impurity; Irinotecan Related Compound Lactone
EINECS	Contact for details

Quality Control

Our Irinotecan Lactone Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
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%
Water Content (KF)	≤ 5.0%
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.