Description

Topotecan-D6 is a deuterated isotopologue of the potent topoisomerase I inhibitor, Topotecan, specifically designed for use as an internal standard in quantitative bioanalytical studies. This high-purity reference material is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolic profiling data, particularly in regulated environments. It is a critical tool for pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories developing and validating LC-MS/MS methods for the parent drug.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard (SIL-IS) for the precise quantification of Topotecan in biological matrices (plasma, serum, urine, tissue homogenates) using LC-MS/MS.
• Pharmacokinetic (PK) Studies: Enables accurate measurement of drug concentration-time profiles, supporting ADME (Absorption, Distribution, Metabolism, Excretion) studies in preclinical and clinical research.
• Method Development & Validation: Critical for developing robust, sensitive, and specific analytical methods that meet regulatory guidelines (e.g., FDA, EMA) for bioanalytical method validation.
• Metabolite Identification & Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in complex biological samples.
• Quality Control in Manufacturing: Can be used in impurity profiling and stability-indicating assays for the parent drug substance and finished pharmaceutical products.

Basic Information

Product Name	Topotecan-D6
CAS No.	1044904-10-0
Molecular Formula	C23H17D6N3O5
Molecular Weight	427.46 g/mol
Synonyms	(S)-10-Hydroxy-9-[(dimethylamino)methyl-d6]-7-ethyl-19,20-dihydro-18H-camptothecin-18-one; 10-Hydroxy-9-[(dimethylamino-d6)methyl]-(20S)-camptothecin; Topotecan (hexadeuterated); Topotecan-d6; Topotecan Internal Standard; Camptothecin, 10-hydroxy-9-[(dimethylamino-d6)methyl]-, (S)-; Deuterated Topotecan
EINECS	Contact for details

Quality Control

Every batch of Topotecan-D6 is manufactured under controlled conditions and undergoes comprehensive analytical characterization to ensure identity, purity, and isotopic enrichment. Our quality assurance protocol includes rigorous testing via NMR, HPLC, and MS to confirm chemical and isotopic purity, typically exceeding 98%. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data. We support compliance with cGMP and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. For long-term storage, keep desiccated under an inert atmosphere. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation.

Specification

Item	Specification
Appearance	Yellow to light brown solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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