Description

Linagliptin Impurity H is a specified impurity of the active pharmaceutical ingredient (API) Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes. This compound is critical for pharmaceutical manufacturers to monitor and control during the drug development and production process to ensure the final product's safety, efficacy, and regulatory compliance. It is primarily used by analytical laboratories and API producers for method development, validation, and as a reference standard in quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Linagliptin drug substance and drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to detect and quantify this specific impurity.
• Quality Control and Assurance: Employed in routine QC testing of Linagliptin API batches to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to monitor the formation of Impurity H over time under various stress conditions to establish product shelf life.
• Regulatory Submissions: Serves as a critical component in regulatory filings (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research and Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemistry of Linagliptin.

Basic Information

Product Name	Linagliptin Impurity H
CAS No.	1646355-34-1
Molecular Formula	C25H28N8O2
Molecular Weight	472.55 g/mol
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 H; (R)-Omarigliptin Impurity H; 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-; Linagliptin Related Compound H
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical impurities. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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