Description

Linagliptin Dimer Impurity 6 is a high-purity reference standard critical for the analytical characterization and quality control of the antidiabetic drug Linagliptin. This impurity is essential for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used in research and development, method validation, and stability studies within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Linagliptin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of this specific dimer impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in studies to understand the degradation pathways and chemistry of Linagliptin.

Basic Information

Product Name	Linagliptin Dimer Impurity 6
CAS No.	1643364-41-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Dimer; Linagliptin Impurity 6; Linagliptin Related Compound 6; BI-1356 Dimer Impurity; 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3,7-dihydro-1-[(4-methylquinazolin-2-yl)methyl]-3-{7-[(3R)-3-aminopiperidin-1-yl]-1-[(4-methylquinazolin-2-yl)methyl]-2,4-dioxo-1,2,3,4-tetrahydropyrido[2,3-d]pyrimidin-8-yl}purine-2,6-dione
EINECS	Contact for details

Quality Control

Our Linagliptin Dimer Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of purity and identity. Each batch is characterized using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided to support your regulatory and quality requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or desiccated conditions upon opening to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.