Description

Linagliptin Impurity C CAS NO 1791405-13-4 is a specified organic impurity associated with the active pharmaceutical ingredient Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring drug safety and regulatory compliance. It is an essential material for research and quality assurance laboratories in the global pharmaceutical and contract research organization (CRO) sectors.

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 & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure batches meet stringent pharmacopeial (USP, EP) and internal specification limits.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Linagliptin Impurity C
CAS No.	1791405-13-4
Molecular Formula	C25H28N8O2
Molecular Weight	472.54 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; BI-1356 Impurity C; (R)-8-(3-Aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione; Linagliptin Related Compound C; Tradjenta Impurity C; Onglyza Impurity C (related); DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity C is manufactured and controlled under a strict quality management system. It undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity (typically ≥95% by HPLC), and analytical data is provided with each shipment.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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.