Description

Irinotecan Hydrochloride Trihydrate is a topoisomerase I inhibitor used as a key active pharmaceutical ingredient (API) in the formulation of injectable chemotherapy drugs. This compound is critical for its role in disrupting DNA replication in cancer cells, offering a vital therapeutic option. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for metastatic colorectal cancer and other malignancies.

Application

• Oncological Drug Manufacturing: Primary use as the active pharmaceutical ingredient (API) in the production of injectable chemotherapy formulations.
• Pharmaceutical R&D: Serves as a critical reference standard and starting material in the development of new anticancer therapies and combination regimens.
• Generic Drug Production: Essential for manufacturers producing generic versions of irinotecan-based cancer treatments.
• Clinical Trial Material: Used in the preparation of investigational medicinal products for oncology clinical trials.
• Biochemical Research: Employed in laboratory studies to investigate mechanisms of topoisomerase I inhibition and cellular apoptosis.

Basic Information

Product Name	Irinotecan Hydrochloride Trihydrate
CAS No.	136572-09-3
Molecular Formula	C33H38N4O6 • HCl • 3H2O
Molecular Weight	677.18 g/mol (as trihydrate)
Synonyms	Irinotecan HCl Trihydrate; CPT-11 Hydrochloride Trihydrate; Camptosar (API form); 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin Hydrochloride Trihydrate; (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 Trihydrate; SN-38 Prodrug Hydrochloride Trihydrate
EINECS	Contact for details

Quality Control

Our Irinotecan Hydrochloride Trihydrate is manufactured and tested under strict quality systems. We ensure compliance with ICH Q7 guidelines and relevant pharmacopeial standards. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	Yellow to light yellow crystalline powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	7.0% - 9.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details
pH (in solution)	Contact for details

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