Description

Linagliptin Impurity K is a specified, 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 product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) departments for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Linagliptin Impurity K in drug substance and drug product batches.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles throughout the drug lifecycle.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to agencies like the US FDA and EMA.
• Quality Control Testing: Employed in routine QC labs to ensure every batch of Linagliptin API meets the stringent impurity limits set in pharmacopeial monographs or internal specifications.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Linagliptin to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Linagliptin Impurity K
CAS No.	1638744-06-5
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; Linagliptin Related Compound K; Linagliptin EP Impurity K; Linagliptin USP Impurity K; BI-1356 Impurity K; 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 K is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (e.g., against a qualified reference standard), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the requirements for chemicals used in pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture, which could affect stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual 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.