Description

Linagliptin Impurity 7 is a designated impurity associated with the active pharmaceutical ingredient 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 primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical and biotechnology industries to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Linagliptin drug substance and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of degradation products under various stress conditions.
• Research & Development: Facilitates studies on the chemical and metabolic pathways of Linagliptin.

Basic Information

Product Name	Linagliptin Impurity 7
CAS No.	2416949-69-2
Molecular Formula	C25H28N8O2
Molecular Weight	472.55 g/mol
Synonyms	BI-1356 Impurity 7; 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 7; Tradjenta Impurity 7; (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 7 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, residual solvent analysis, and structural confirmation (NMR, MS), to ensure identity, purity, and traceability. Certificates of Analysis (COA) containing detailed test results against predefined specifications are provided and are available upon request to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
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.