Description

Irinotecan Impurity G is a specified impurity of the chemotherapeutic agent Irinotecan Hydrochloride, a critical component in pharmaceutical development and quality control. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a reference standard for analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the development, validation, and batch release testing of Irinotecan-based formulations. The precise characterization and control of this impurity are fundamental to meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Irinotecan Impurity G in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Quality Control & Batch Release: Critical for routine quality control testing to ensure impurity levels in commercial batches comply with ICH guidelines and regulatory specifications.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to monitor impurity formation over time.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Irinotecan.

Basic Information

Item	Detail
Product Name	Irinotecan Impurity G
CAS No.	947687-02-7
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 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]quinolin-9-yl [1,4'-bipiperidine]-1'-carboxylate; 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Impurity G; CPT-11 Impurity G; Irinotecan Related Compound G
EINECS	Contact for details

Quality Control

Every batch of Irinotecan Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A, Q3B, and relevant pharmacopeial guidelines. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white 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% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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