Description

Linagliptin CAS NO 668270-12-0 is a highly selective, orally active dipeptidyl peptidase-4 (DPP-4) inhibitor used as an active pharmaceutical ingredient (API). This compound is critical for the development and manufacture of advanced antidiabetic medications, offering a targeted mechanism of action for glycemic control. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the production of treatments for type 2 diabetes mellitus.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral antidiabetic tablets for the management of type 2 diabetes.
• Fixed-Dose Combination Drugs: Used in combination with other antidiabetic agents like metformin for enhanced therapeutic efficacy.
• Clinical Research: Serves as a reference standard and investigational compound in pharmacokinetic and pharmacodynamic studies.
• Formulation Development: Utilized in R&D for developing novel drug delivery systems and dosage forms.
• Generic Drug Manufacturing: A key component for companies producing bioequivalent versions of branded DPP-4 inhibitor medications.
• Biochemical Research: Used as a selective tool to study DPP-4 enzyme inhibition and related metabolic pathways in laboratory settings.

Basic Information

Product Name	Linagliptin
CAS No.	668270-12-0
Molecular Formula	C25H28N8O2
Molecular Weight	472.54 g/mol
Synonyms	BI 1356; Tradjenta® (Brand Name); 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione; (R)-8-(3-Aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione; 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-
EINECS	Contact for details

Quality Control

Our Linagliptin is manufactured under strict quality management systems, targeting high purity suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing including HPLC, IR spectroscopy, and residual solvent analysis. A Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to ensure compliance with customer specifications and support regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm
Residue on Ignition	≤ 0.1%

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