Description

Linagliptin Impurity 28 is a specified impurity associated with the active pharmaceutical ingredient (API) Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Linagliptin-based drug products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Linagliptin API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for compliance with ICH guidelines.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) laboratories to set specification limits.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Valuable for research and development of Linagliptin generics and process optimization.

Basic Information

Product Name	Linagliptin Impurity 28
CAS No.	2074688-84-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Related Compound 28; Linagliptin EP Impurity 28; Linagliptin USP Impurity 28; 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 28; Tradjenta Impurity 28; (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 28 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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