Description

Topotecan (Tpt) is a potent semi-synthetic derivative of camptothecin, functioning as a topoisomerase I inhibitor. This mechanism is critical for its role as a key active pharmaceutical ingredient (API) in targeted cancer chemotherapy. It is primarily utilized by pharmaceutical manufacturers and research institutions in the oncology sector. The compound is supplied under stringent quality control to ensure efficacy and safety in final drug formulations.

Application

• Oncological Pharmaceutical Manufacturing: Primary use as the active pharmaceutical ingredient (API) in injectable formulations for chemotherapy.
• Treatment of Ovarian Cancer: A cornerstone in second-line therapy for metastatic ovarian carcinoma.
• Treatment of Small Cell Lung Cancer (SCLC): Used as a therapeutic agent for recurrent SCLC.
• Cervical Cancer Therapy: Employed in treatment protocols for recurrent or metastatic cervical cancer.
• Pediatric Oncology: Investigated and used in certain pediatric solid tumors and leukemias.
• Biomedical Research: Serves as a critical reference standard and tool compound in cancer biology and pharmacology studies.
• Drug Combination Studies: Used in research exploring synergistic effects with other chemotherapeutic agents.
• Formulation Development: Essential for R&D focused on novel drug delivery systems like liposomes or nanoparticles to improve therapeutic profiles.

Basic Information

Product Name	Topotecan (Tpt)
CAS No.	139339-45-0
Molecular Formula	C23H23N3O5
Molecular Weight	421.45 g/mol
Synonyms	Topotecan; Tpt; (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 standards suitable for pharmaceutical application. Each batch is subjected to comprehensive analytical testing including identification, purity assay, and impurity profiling. A Certificate of Analysis (COA) is provided, detailing results against specifications for parameters such as assay (by HPLC), related substances, residual solvents, and chiral purity. We support compliance with ICH Q7 guidelines and relevant pharmacopeial standards (e.g., USP, EP) upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Due to its hygroscopic nature, the container must be kept tightly sealed after each use to minimize exposure to atmospheric moisture. For long-term stability, storage under an inert atmosphere (e.g., nitrogen) is recommended.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5% (on anhydrous basis)
Chiral Purity (HPLC)	≥ 99.0% (S-isomer)
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 2.0%
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.