Description

Linagliptin-13C, D3 is a stable isotope-labeled analog of the antidiabetic drug Linagliptin, specifically enriched with carbon-13 and deuterium. This high-purity reference material is essential for conducting precise and reliable quantitative bioanalytical studies, including pharmacokinetics and metabolism research. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions focused on developing and validating advanced LC-MS/MS methods for drug analysis.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical internal standard for the accurate quantification of Linagliptin in biological matrices such as plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in mass spectrometry-based assays to study the absorption, distribution, metabolism, and excretion (ADME) profile of Linagliptin.
• Clinical Research and Bioequivalence Testing: Enables precise measurement of drug concentrations in clinical trial samples to assess bioavailability and bioequivalence.
• Forensic and Anti-Doping Analysis: Supports highly specific and sensitive detection methods in forensic toxicology and sports anti-doping controls.
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with regulatory guidelines (e.g., FDA, EMA).
• Quality Control in Pharmaceutical Manufacturing: Can be utilized in impurity profiling and stability-indicating assays during drug product development.

Basic Information

Product Name	Linagliptin-13C, D3
CAS No.	1398044-43-3
Molecular Formula	C2513C1H25D3N8O2
Molecular Weight	~475.55 g/mol
Synonyms	8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione-13C, D3; BI 1356-13C, D3; Tradjenta-13C, D3; (R)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione-13C, D3; Linagliptin (13C, D3); Deuterated and Carbon-13 Labeled Linagliptin
EINECS	Contact for details

Quality Control

Our Linagliptin-13C, D3 is manufactured under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity (by HPLC), isotopic enrichment (by MS), and residual solvent content. We support research requiring compliance with GMP/GLP principles, and specifications can be aligned with pharmacopeial standards 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. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (13C)	≥ 99 atom % 13C
Isotopic Purity (D)	≥ 98 atom % D
Chemical Purity (by HPLC)	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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