Description

12-Hydroxy Irinotecan is a significant metabolite and active intermediate of the potent chemotherapeutic agent Irinotecan HCl. This compound is of critical importance in pharmaceutical research and development, particularly for studying drug metabolism, pharmacokinetics, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily utilized by research institutions, pharmaceutical manufacturers, and contract development and manufacturing organizations (CDMOs) engaged in oncology drug development and analytical method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and qualification of Irinotecan and its metabolites in drug substance and finished product analysis.
• Metabolite Research: Essential for in-vitro and in-vivo studies investigating the metabolic pathways, efficacy, and toxicity profile of Irinotecan-based therapies.
• Active Pharmaceutical Ingredient (API) Synthesis: Serves as a key synthetic intermediate in the production and process development of Irinotecan and its derivative compounds.
• Analytical Method Development: Critical for developing and validating robust HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Preclinical and Clinical Studies: Employed in bioanalytical assays to monitor drug levels and metabolite formation during pharmacological and toxicological evaluations.

Basic Information

Product Name	12-Hydroxy Irinotecan
CAS No.	185336-12-3
Molecular Formula	C33H38N4O7
Molecular Weight	602.68 g/mol
Synonyms	SN-38 Glucuronide; 7-Ethyl-10-hydroxycamptothecin glucuronide; 10-Hydroxy-7-ethylcamptothecin glucuronide; Irinotecan metabolite; CPT-11 metabolite; (4S)-4,11-Diethyl-4-hydroxy-9-[(2S,3S,4S,5R,6S)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione
EINECS	Contact for details

Quality Control

Our 12-Hydroxy Irinotecan is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical research. Certificates of Analysis (COA) detailing all specifications and test results are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider desiccant and under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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