Description

Linagliptin Impurity S is a high-purity chemical reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of the antidiabetic drug Linagliptin by enabling the accurate identification and quantification of related substances during manufacturing. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical development and production. The material is supplied with comprehensive analytical data to support regulatory compliance and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Linagliptin drug substance and finished products.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to establish impurity profiles and ensure batch-to-batch consistency of Linagliptin API.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to identify and track degradation products formed during the stability testing of Linagliptin formulations.
• Research and Development: Used in pharmaceutical R&D for studying the degradation pathways and metabolism of Linagliptin.

Basic Information

Item	Details
Product Name	Linagliptin Impurity S
CAS No.	668273-74-3
Molecular Formula	C25H28N8O2
Molecular Weight	472.55 g/mol
Synonyms	1-[(4-Methylquinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-[(3R)-3-aminopiperidin-1-yl]-1H-purine-2,6(3H,7H)-dione; BI-1356 Impurity S; (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 S; Tradjenta Impurity S
EINECS	Contact for details

Quality Control

Every batch of Linagliptin Impurity S is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and ensure high purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results for identity, assay, purity, and related substances. Our quality protocols are designed to support compliance with ICH Q3A, Q3B, and cGMP guidelines for pharmaceutical impurities.

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 storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.