Description

Irinotecan Hydrochloride is a potent topoisomerase I inhibitor and a key active pharmaceutical ingredient (API) in the treatment of metastatic colorectal cancer and other malignancies. Its clinical significance lies in its ability to interfere with DNA replication in cancer cells, making it a cornerstone of modern chemotherapy regimens. This high-purity compound is essential for pharmaceutical manufacturers engaged in the production of injectable oncology drugs, as well as for research institutions developing novel therapeutic formulations and conducting pharmacological studies.

Application

• Oncological Drug Manufacturing: Primary use as the active pharmaceutical ingredient (API) in the formulation of injectable chemotherapy drugs, such as Camptosar® and generic equivalents.
• Pharmaceutical Research & Development: Serves as a critical reference standard and starting material for developing new drug delivery systems, combination therapies, and next-generation topoisomerase inhibitors.
• Clinical Trial Material (CTM): Used in the production of materials for clinical trials investigating new indications, dosing schedules, or combination treatments for various cancers.
• Analytical Standard: Employed in quality control laboratories as a high-purity reference standard for HPLC, LC-MS, and other analytical methods to ensure batch consistency and regulatory compliance.
• Academic & Biomedical Research: Utilized in university and institutional labs to study mechanisms of drug action, resistance, and cellular apoptosis in cancer biology.

Basic Information

Product Name	Irinotecan Hydrochloride
CAS No.	100286-90-6
Molecular Formula	C33H38N4O6 • HCl
Molecular Weight	623.14 g/mol (as hydrochloride salt)
Synonyms	CPT-11 Hydrochloride; Irinotecan HCl; Camptosar (brand name); (S)-4,11-Diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate hydrochloride; 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin hydrochloride; NSC 616348
EINECS	Contact for details

Quality Control

Our Irinotecan Hydrochloride is manufactured under strict quality management systems to meet the rigorous standards required for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure compliance with ICH guidelines and relevant pharmacopeial monographs (e.g., USP, EP). A detailed Certificate of Analysis (COA) documenting purity, related substances, and other critical parameters is provided with every shipment to guarantee traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to light yellow crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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