Description

Linagliptin Impurity G is a specified impurity and degradation product of the antidiabetic drug Linagliptin. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Linagliptin drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Linagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and regulatory filings to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Linagliptin to minimize the formation of this specific impurity.

Basic Information

Product Name	Linagliptin Impurity G
CAS No.	668270-11-9
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; (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; BI-1356 Impurity G; Tradjenta Impurity G; Linagliptin Related Compound G
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity, related substances, residual solvents, and other relevant tests. We support compliance with ICH guidelines and can provide materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.