Description

Topotecan Acid Sodium Salt is a key pharmaceutical intermediate and active pharmaceutical ingredient (API) derived from the potent anticancer agent, topotecan. This compound is critical for the synthesis and formulation of injectable chemotherapeutic drugs used in targeted cancer treatments. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in oncology drug development and production.

Application

• Pharmaceutical API Synthesis: Primary use as an intermediate in the commercial manufacturing of Topotecan Hydrochloride, a topoisomerase I inhibitor.
• Oncology Drug Formulation: Essential raw material for producing finished dosage forms, particularly lyophilized powders for injection.
• Clinical Research & Development: Serves as a reference standard and starting material in preclinical and clinical studies for novel cancer therapies.
• Generic Drug Production: A vital component for companies developing and manufacturing generic versions of topotecan-based chemotherapy drugs.
• Biochemical Research: Used in laboratory studies to investigate mechanisms of topoisomerase inhibition and cellular apoptosis.

Basic Information

Product Name	Topotecan Acid Sodium Salt
CAS No.	132877-29-3
Molecular Formula	C23H22N3NaO5
Molecular Weight	443.43 g/mol
Synonyms	(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 Sodium Salt; Topotecan Sodium Salt; SKF 104864-A Sodium Salt; Hycamtin Acid Sodium Salt; 9-Dimethylaminomethyl-10-hydroxycamptothecin Sodium Salt; (S)-9-[(Dimethylamino)methyl]-10-hydroxycamptothecin Sodium Salt
EINECS	Contact for details

Quality Control

Our Topotecan Acid Sodium Salt is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is tested to ensure compliance with stringent internal specifications for identity, purity, and impurity profiles. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological attributes is provided with every shipment to support your regulatory and 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). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets Ph. Eur. / USP criteria for non-sterile substances

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