Description

Linagliptin Impurity 33 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antidiabetic drug Linagliptin. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Linagliptin Impurity 33 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during drug manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Linagliptin API meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research on Degradation Pathways: Serves as a tool in research to understand the chemical degradation pathways of Linagliptin.

Basic Information

Product Name	Linagliptin Impurity 33
CAS No.	2443735-53-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linagliptin Related Compound 33; Linagliptin EP Impurity 33; Linagliptin USP Impurity 33; BI-1356 Impurity 33; 8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione (proposed); Tradjenta Impurity 33; (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 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are 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 controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
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.