Description

Topotecan is a semi-synthetic derivative of camptothecin, functioning as a potent topoisomerase I inhibitor. This mechanism is critical for its role as a key active pharmaceutical ingredient (API) in targeted cancer chemotherapy formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions developing treatments for ovarian cancer, small cell lung cancer, and cervical cancer. The compound's efficacy hinges on its high purity and stability, which are paramount for ensuring consistent therapeutic outcomes.

Application

• Oncological Pharmaceutical Manufacturing: As the core API in injectable formulations for chemotherapy.
• Clinical Research & Development: For investigating new combination therapies and treatment protocols for solid tumors.
• Reference Standard Production: Serves as a high-purity standard for analytical testing and quality control in pharmacopeial (USP/EP) methods.
• Drug Discovery: Used as a lead compound or biochemical tool in cancer biology research to study topoisomerase I inhibition.
• Generic Drug Formulation: Essential for manufacturers producing bioequivalent versions of branded topotecan hydrochloride therapies.

Basic Information

Product Name	Topotecan
CAS No.	123948-87-8
Molecular Formula	C23H23N3O5
Molecular Weight	421.45 g/mol
Synonyms	Topotecan; (S)-10-[(Dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione; Hycamtin (Brand Name); SKF 104864; NSC 609699; 9-Dimethylaminomethyl-10-hydroxycamptothecin; (S)-Topotecan
EINECS	Contact for details

Quality Control

Our Topotecan is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing, including HPLC for assay and related substances, residual solvent analysis, and identification by spectroscopic methods. A Certificate of Analysis (COA) detailing purity, impurities, and other critical parameters is provided with each batch to ensure traceability and compliance with your quality requirements.

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. Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and potency.

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% - 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
Specific Rotation	-40.0° to -48.0° (c=1 in DMF)

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