Description

Irinotecan CAS NO 97682-44-5 is a topoisomerase I inhibitor and a semi-synthetic derivative of camptothecin, widely recognized as a key active pharmaceutical ingredient (API) in oncology. Its primary value lies in its critical role as the active component in chemotherapeutic regimens for treating metastatic colorectal cancer and other solid tumors. This high-purity compound is essential for pharmaceutical manufacturers, research institutions, and compounding facilities engaged in the development and production of injectable chemotherapy drugs and novel targeted cancer therapies.

Application

• Oncological Pharmaceutical Manufacturing: As the core API in the formulation of injectable chemotherapy drugs such as Camptosar® and generic equivalents for the treatment of colorectal cancer.
• Clinical Research & Drug Development: Serving as a reference standard and a building block in preclinical and clinical studies for new combination therapies and dosage forms.
• Pharmaceutical Compounding: Used in specialized pharmacy settings for preparing patient-specific doses in accordance with clinical protocols.
• Bioscience Research: A vital tool in molecular biology and pharmacology research to study topoisomerase I inhibition, DNA damage mechanisms, and apoptosis in cancer cell lines.
• Generic Drug Production: A fundamental ingredient for manufacturers producing bioequivalent versions of branded irinotecan hydrochloride trihydrate injectable solutions.
• Academic Research: Utilized in university and institutional labs for chemical, pharmacological, and toxicological studies related to camptothecin analogs.

Basic Information

Item	Details
Product Name	Irinotecan
CAS No.	97682-44-5
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	Irinotecan Hydrochloride; Irinotecan HCl; CPT-11; Camptosar®; 7-Ethyl-10-[4-(1-piperidino)-1-piperidino]carbonyloxycamptothecin; (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; 7-Ethyl-10-hydroxycamptothecin 10-[1,4'-bipiperidine]-1'-carboxylate
EINECS	Contact for details

Quality Control

Our Irinotecan is manufactured under strict quality 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, typically via HPLC, IR, and other pharmacopeial methods. We provide full traceability and Certificates of Analysis (COA) that detail compliance with in-house specifications aligned with major pharmacopeia guidelines. Our commitment ensures a reliable supply of material suitable for GMP manufacturing and critical research.

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 specified on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.