Description

Linagliptin Impurity CAS NO 2140263-92-7 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antidiabetic active pharmaceutical ingredient (API) Linagliptin. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Linagliptin API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Used to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Linagliptin.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability test component and for routine batch release testing in GMP environments.

Basic Information

Product Name	Linagliptin Impurity
CAS No.	2140263-92-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Related Compound; Linagliptin Process Impurity; 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione impurity; BI-1356 Impurity; Tradjenta Impurity; (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 impurity
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity CAS 2140263-92-7 is manufactured and analyzed under strict quality management systems. Comprehensive testing is performed using advanced analytical techniques (HPLC, LC-MS, NMR) to confirm identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference material applications.

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 absorption of moisture. 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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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