Description

Linagliptin Impurity Kh-3 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antidiabetic drug Linagliptin. This impurity is critical for pharmaceutical manufacturers and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent ICH guidelines. It is primarily utilized by research and development laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the development and production of Linagliptin and its formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Kh-3 in Linagliptin Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Linagliptin.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control Testing: Employed in routine batch release testing to ensure Linagliptin API and drug products meet predefined impurity specification limits.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Linagliptin synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Linagliptin Impurity Kh-3
CAS No.	2279114-27-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 Kh-3; Tradjenta Impurity Kh-3; Linagliptin Related Compound Kh-3; 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-; (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
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity Kh-3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive); therefore, the container should be kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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