Description

Linagliptin Impurity F CAS NO 1673546-62-7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antidiabetic drug Linagliptin by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and quality control laboratories. The precise characterization of such impurities is fundamental to meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Linagliptin Impurity F in active pharmaceutical ingredient (API) and finished drug product testing.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) methods.
• Quality Control and Assurance: Used in routine QC testing to monitor impurity profiles, ensure batch-to-batch consistency, and guarantee that Linagliptin API meets specified purity limits (e.g., ICH Q3A/B guidelines).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation pathway of this impurity and develop processes to minimize its generation.

Basic Information

Product Name	Linagliptin Impurity F
CAS No.	1673546-62-7
Molecular Formula	C25H28N8O2
Molecular Weight	472.55 g/mol
Synonyms	8-[(3R)-3-Aminopiperidin-1-yl]-7-but-2-ynyl-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 F; Tradjenta Impurity F; Linagliptin Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations and ICH Q3A (R2) and Q3B (R2) guidelines for impurities in new drug substances and products. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced chromatographic and spectroscopic analyses. Our quality commitment supports our customers' needs for reliable and traceable reference standards in regulatory submissions and GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to ensure optimal stability.

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
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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