Description

Linagliptin n-Acetyl Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the antidiabetic active pharmaceutical ingredient (API) Linagliptin. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Linagliptin drug substance and finished products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits for impurity monitoring.
• Stability Studies & Forced Degradation: Employed to identify and quantify degradation products in Linagliptin formulations under various stress conditions (e.g., heat, humidity, light).
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Linagliptin API and drug products meet stringent pharmacopeial (USP, EP) impurity limits.
• Regulatory Documentation & Submission: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies.
• Research on Metabolic Pathways: Used in studies investigating the metabolism and pharmacokinetics of Linagliptin.

Basic Information

Product Name	Linagliptin n-Acetyl Impurity
CAS No.	1803079-49-3
Molecular Formula	C28H33N7O3
Molecular Weight	515.61 g/mol
Synonyms	N-Acetyl Linagliptin; 1-[(4-Methylquinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-[(3R)-3-aminopiperidin-1-yl]-N-acetylxanthine; Linagliptin Acetyl Impurity; Linagliptin Impurity (n-Acetyl); BI-1356 n-Acetyl Impurity; (R)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-N-acetyl-1H-purine-2,6(3H,7H)-dione
EINECS	Contact for details

Quality Control

Our Linagliptin n-Acetyl Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards for pharmaceutical impurities.

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.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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