Description

Topotecan-D5 is a deuterated internal standard of the topoisomerase I inhibitor Topotecan, specifically designed for use in quantitative analytical methods. This high-purity reference material is critical for ensuring the accuracy and reliability of pharmacokinetic and bioanalytical studies in pharmaceutical research and development. It is an essential tool for scientists and quality control laboratories in the pharmaceutical, contract research organization (CRO), and academic sectors who require precise and stable isotopic standards for mass spectrometry (LC-MS/MS).

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise quantification of Topotecan in biological matrices (plasma, serum, urine) using LC-MS/MS.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to support clinical trials and drug development.
• Method Development and Validation: Used as a critical component in developing, optimizing, and validating robust analytical methods in compliance with GLP and GCP guidelines.
• Drug Metabolism Studies: Facilitates research into the metabolic pathways and stability of Topotecan.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification during the production of Topotecan Active Pharmaceutical Ingredient (API) and finished dosage forms.

Basic Information

Product Name	Topotecan-D5
CAS No.	1133355-98-2
Molecular Formula	C23H18D5N3O5
Molecular Weight	424.45 g/mol
Synonyms	(S)-10-[(Dimethylamino)methyl-d5]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione; Topotecan (methyl-d5); Topotecan-d5; Deuterated Topotecan; Topotecan Internal Standard; 9-Dimethylamino-10-[(methyl-d3)(methyl-d2)amino]methyl-(S)-camptothecin
EINECS	Contact for details

Quality Control

Our Topotecan-D5 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), chemical purity, isotopic purity (D-enrichment), and residual solvents. We support compliance with cGMP and ISO 9001 standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH guidelines

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