Description

Linagliptin Impurity 38 is a high-purity chemical reference standard used in the analytical profiling of the antidiabetic drug Linagliptin. This compound is critical for pharmaceutical research and development, enabling precise identification, quantification, and control of process-related impurities to ensure drug safety and efficacy. It is an essential material for quality control laboratories, analytical method development, and regulatory compliance within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Linagliptin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control and Assurance: Used in routine batch release testing to monitor impurity levels and ensure product specifications are met according to pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specification limits in regulatory dossiers.
• Process Chemistry Research: Aids in understanding and optimizing the Linagliptin synthesis pathway to minimize the formation of this impurity during manufacturing.

Basic Information

Item	Details
Product Name	Linagliptin Impurity 38
CAS No.	1979144-52-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Related Compound 38; Linagliptin EP Impurity G; Linagliptin USP Impurity; BI-1356 Impurity 38; 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-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione; Linagliptin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity 38 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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