Description

Topotecan Hydrochloride is a potent semi-synthetic derivative of camptothecin, functioning as a topoisomerase I inhibitor. This mechanism is critical for disrupting DNA replication in rapidly dividing cells, making it a cornerstone in targeted cancer chemotherapy. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in oncology drug development and production. The compound is supplied under stringent quality controls to ensure reliability for critical therapeutic applications.

Application

• Oncological Pharmaceutical Manufacturing: Active Pharmaceutical Ingredient (API) for injectable formulations used in chemotherapy.
• Treatment of Ovarian Cancer: A key therapeutic agent, particularly in cases where first-line therapies have failed.
• Treatment of Small Cell Lung Cancer (SCLC): Used as a second-line treatment option.
• Cervical Cancer Therapy: Employed in combination regimens for advanced or recurrent disease.
• Biomedical Research: A vital tool for studying topoisomerase I inhibition, DNA damage mechanisms, and cancer cell apoptosis.
• Drug Discovery & Development: Serves as a reference standard and a lead compound for developing novel camptothecin analogs.
• Hospital & Compounding Pharmacy: Source material for preparing specialized chemotherapeutic preparations under controlled environments.

Basic Information

Product Name	Topotecan Hydrochloride
CAS No.	119413-54-6
Molecular Formula	C23H23N3O5 • HCl
Molecular Weight	457.91 g/mol (as hydrochloride)
Synonyms	Topotecan HCl; (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 hydrochloride; Hycamtin (Brand Name); SKF 104864-A; NSC 609699; 9-Dimethylaminomethyl-10-hydroxycamptothecin hydrochloride
EINECS	Contact for details

Quality Control

Our Topotecan Hydrochloride is manufactured and tested to meet the exacting standards required for pharmaceutical active ingredients. Quality assurance protocols align with current Good Manufacturing Practices (cGMP). Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring traceability and compliance for regulatory submissions. Certificates are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), or as specified on the label. The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	Yellow to greenish-yellow powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Specific Rotation	Contact for details

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