Description

Topotecan-D6 Carboxylic Acid Sodium Salt is a high-purity, isotopically labeled derivative of the topoisomerase I inhibitor topotecan. This compound is specifically designed for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical research and development laboratories, contract research organizations (CROs), and academic institutions focused on oncology drug development and analytical chemistry.

Application

• Primary use as an Internal Standard (IS) for LC-MS/MS analysis in bioanalytical method development and validation.
• Quantification of topotecan and its metabolites in complex biological matrices such as plasma, serum, and tissue homogenates.
• Supporting pharmacokinetic (PK) and pharmacodynamic (PD) studies for novel camptothecin analogs and related anticancer agents.
• Drug metabolism and disposition (DMPK) research to understand absorption, distribution, metabolism, and excretion (ADME) profiles.
• Use in regulated Good Laboratory Practice (GLP) and clinical trial sample analysis to ensure data integrity.
• Stability-indicating assays and impurity profiling of pharmaceutical formulations containing topotecan.

Basic Information

Product Name	Topotecan-D6 Carboxylic Acid Sodium Salt
CAS No.	1263470-27-4
Molecular Formula	C₂₃H₁₇D₆N₃O₅•Na
Molecular Weight	~457.45 g/mol
Synonyms	Topotecan-d6 Sodium Salt; (S)-10-[(Dimethylamino)methyl]-4-ethyl-d6-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione Carboxylic Acid Sodium Salt; 9-[(Dimethylamino)methyl]-10-[(dideuterio)(2H3)methyl]-(5S)-5,9-dihydroxy-4,5,6,13-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(12H)-dione Sodium Salt; Deuterated Topotecan Sodium Salt; SKF 104864A-d6 Sodium Salt; Isotopically Labeled Topotecan Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Topotecan-D6 Carboxylic Acid Sodium Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and isotopic enrichment. Our quality assurance protocol is designed to meet the exacting standards required for bioanalytical internal standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, isotopic purity, chemical purity, and residual solvents. We support compliance with ICH Q3 guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. This material is hygroscopic (moisture-sensitive). For long-term storage, consider desiccant and under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC/MS)	Conforms
Assay (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98.0 atom % D
Chemical Purity (HPLC)	≥95.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Water Content (KF)	≤5.0%

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