Description

Linagliptin Impurity 26 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the antidiabetic drug Linagliptin, ensuring the safety and efficacy of the final pharmaceutical product. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality assurance teams for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Linagliptin API and finished dosage forms.
• Analytical Method Development and validation in HPLC, UPLC, and LC-MS systems.
• Quality Control & Assurance (QC/QA) testing to meet ICH guidelines and regulatory submission requirements (e.g., FDA, EMA).
• Stability Studies to monitor impurity profiles under various stress conditions.
• Research & Development for studying the degradation pathways and metabolism of Linagliptin.
• Certification of Analysis (COA) Preparation to provide batch-specific impurity data.

Basic Information

Product Name	Linagliptin Impurity 26
CAS No.	2446799-71-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Related Compound 26; BI-1356 Impurity 26; 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione; Tradjenta Impurity 26; (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; Linagliptin EP Impurity G; Linagliptin USP Impurity
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity 26 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and related substances.

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 product 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)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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