Description

Topotecan Carboxylic Acid Sodium Salt is a key pharmaceutical intermediate and impurity standard in the synthesis of the potent anticancer drug Topotecan. This high-purity compound is critical for ensuring the efficacy, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in oncology drug development, quality control, and process optimization.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the Topotecan API.
• Reference Standard: Used as an analytical standard in HPLC and LC-MS methods for quantifying impurities and ensuring batch-to-batch consistency of Topotecan.
• Process Development & Research: Employed in route scouting, process optimization, and scale-up studies for Topotecan manufacturing.
• Quality Control (QC) & Quality Assurance (QA): Essential for identity confirmation, assay, and related substance testing in pharmaceutical QC/QA laboratories.
• Regulatory Compliance: Supports the generation of data for regulatory filings (e.g., FDA, EMA) by providing a characterized impurity standard.

Basic Information

Product Name	Topotecan Carboxylic Acid Sodium Salt
CAS No.	123949-08-6
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 carboxylic acid sodium salt; Topotecan acid sodium salt; Topotecan carboxylate sodium salt; CPT-11 carboxylic acid sodium salt derivative
EINECS	Contact for details

Quality Control

Our Topotecan Carboxylic Acid Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, to ensure it meets stringent specifications suitable for pharmaceutical development. A Certificate of Analysis (COA) detailing all test results 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 controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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