Description

Irinotecan Hydroxyl Acid is a key pharmaceutical intermediate and the primary active metabolite of the important chemotherapeutic agent Irinotecan HCl. This compound is critical for the synthesis and quality control of finished oncology drug products, ensuring their potency and therapeutic efficacy. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of topoisomerase I inhibitor-based cancer treatments.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Serves as the crucial precursor in the manufacturing of Irinotecan Hydrochloride and related prodrug formulations.
• Pharmaceutical Reference Standard: Used as a high-purity analytical standard for the identification and quantification of Irinotecan and its metabolites in drug substances and finished products.
• Metabolite Research: Essential for pharmacokinetic and pharmacodynamic studies to understand the metabolism, efficacy, and toxicity profile of Irinotecan therapy.
• Quality Control & Assurance: Employed in HPLC and other analytical methods to validate the purity, potency, and stability of chemotherapeutic batches.
• Oncology Drug Development: A vital building block in research programs aimed at developing new camptothecin analog derivatives or improved drug delivery systems.
• Impurity Profiling: Used to identify, monitor, and control related substances and degradation products during API manufacturing.

Basic Information

Item	Details
Product Name	Irinotecan Hydroxyl Acid
CAS No.	142677-15-4
Molecular Formula	C33H38N4O6
Molecular Weight	586.68 g/mol
Synonyms	SN-38; 7-Ethyl-10-hydroxycamptothecin; Irinotecan metabolite; (S)-10-Hydroxy-7-ethylcamptothecin; 7-Ethyl-10-hydroxycamptothecin; CPT-11 active metabolite; 4(S)-4,11-Diethyl-4-hydroxy-9-[(4-piperidinopiperidino)carbonyloxy]-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione hydroxyl acid
EINECS	Contact for details

Quality Control

Our Irinotecan Hydroxyl Acid is manufactured under strict quality systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability, consistency, and compliance with relevant industry standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption, which can affect stability and purity. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.