Description

Linagliptin Impurity 10 is a specified impurity associated with the antidiabetic drug Linagliptin, identified by CAS No. 1911621-52-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation, stability studies, and ensuring the purity and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in quality control and compliance for Linagliptin-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Linagliptin API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Linagliptin and to establish appropriate shelf-life specifications.
• Quality Control and Batch Release Testing: A critical component in the routine QC testing of Linagliptin to ensure it meets pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the impurity profile of the drug substance.
• Research and Synthesis Purification: Used by chemists to identify and isolate this impurity during process development and scale-up of Linagliptin synthesis.

Basic Information

Product Name	Linagliptin Impurity 10
CAS No.	1911621-52-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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; BI-1356 Impurity 10; Tradjenta Impurity 10; (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 Related Compound 10
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity 10 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) are provided, detailing batch-specific results and confirming compliance with relevant ICH guidelines. We support our clients' regulatory needs with comprehensive documentation.

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 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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