Description

Linagliptin Impurity Kh-2 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 the safety, efficacy, and regulatory compliance of the final drug product. It is primarily utilized by professionals in pharmaceutical research and development, quality assurance, and regulatory affairs for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Linagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels according to ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Aids in understanding and optimizing the Linagliptin synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Linagliptin Impurity Kh-2
CAS No.	2279114-31-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	BI-1356 Impurity Kh-2; Tradjenta Impurity Kh-2; 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; Linagliptin Related Compound Kh-2; Linagliptin Process Impurity; Linagliptin Degradant
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity Kh-2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR spectroscopy. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring compliance with current pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances and products.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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