Description

Lansoprazole-13C6 is a stable isotope-labeled analog of the proton pump inhibitor Lansoprazole, where six carbon atoms are replaced with the carbon-13 isotope. This compound is essential as a high-purity internal standard for the precise and accurate quantification of Lansoprazole in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is a critical material for pharmaceutical R&D laboratories, clinical research organizations, and regulatory bodies focused on bioanalytical method development, pharmacokinetic studies, and drug metabolism research.

Application

• Bioanalytical Method Development: Serves as an internal standard for developing and validating sensitive and specific LC-MS/MS methods for Lansoprazole quantification.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles in plasma, serum, and other biological fluids.
• Drug Metabolism and Excretion Studies: Used in mass spectrometry to trace and quantify metabolites, aiding in understanding the drug's metabolic fate.
• Clinical Research and Therapeutic Drug Monitoring (TDM): Supports studies on drug efficacy, safety, and optimal dosing regimens in patient populations.
• Regulatory Submission and Compliance: Provides the traceability and accuracy required for data submitted to agencies like the FDA and EMA.
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in advanced QC labs for impurity profiling and assay verification of Lansoprazole API and formulations.

Basic Information

Product Name	Lansoprazole-13C6
CAS No.	1261394-42-6
Molecular Formula	C1613C6H14F3N3O2S
Molecular Weight	~377.36 g/mol (for 13C6 labeled form)
Synonyms	Lansoprazole (13C6); 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl-13C6]methyl]sulfinyl]-1H-benzimidazole; AG-1749-13C6; Prevacid-13C6; Lanzor-13C6; Ogast-13C6; Proton-pump inhibitor-13C6 (labeled); Isotopically Labeled Lansoprazole
EINECS	Contact for details

Quality Control

Our Lansoprazole-13C6 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive mass spectrometry applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (Atom % 13C), chemical purity (by HPLC), and confirmation of structure (by NMR and MS). We adhere to relevant industry standards for reference materials. Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (Atom % 13C)	≥99% on the labeled positions
Chemical Purity (by NMR)	Conforms
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.