Description

Linagliptin Impurity Jx is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Linagliptin, a medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities during the analysis of Linagliptin API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Linagliptin batches to ensure they meet stringent pharmacopeial (USP, EP) specifications for impurity limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Stability Studies: Employed to monitor the formation of degradation products in Linagliptin formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in academic and industrial R&D to study the degradation pathways, metabolism, and chemical behavior of Linagliptin and related compounds.

Basic Information

Product Name	Linagliptin Impurity Jx
CAS No.	2137744-33-1
Molecular Formula	C25H28N8O2
Molecular Weight	472.54 g/mol
Synonyms	8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione; BI 1356 Impurity Jx; (R)-8-(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; Tradjenta Impurity Jx; Linagliptin Related Compound Jx; 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 Impurity Jx is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, NMR, and mass spectrometry for structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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