Description

Alogliptin Impurity 12 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. It is primarily required by analytical laboratories, quality assurance departments, and research institutions involved in the synthesis and validation of antidiabetic medications. The material is supplied with comprehensive analytical data to support regulatory filings and stringent in-house testing protocols.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Alogliptin API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for compliance with ICH guidelines.
• Essential for stability studies and forced degradation studies to profile impurity formation pathways.
• Used in quality control (QC) and quality assurance (QA) laboratories to establish specification limits.
• Supports regulatory submissions (e.g., for FDA, EMA) by providing authenticated impurity data.
• Serves as a research tool in pharmacokinetic and metabolic studies of DPP-4 inhibitors.
• Applied in the calibration of laboratory equipment used in pharmaceutical analysis.

Basic Information

Product Name	Alogliptin Impurity 12
CAS No.	2749281-73-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alogliptin Related Compound 12; Alogliptin Impurity; Alogliptin EP Impurity; Benzoic acid, 2-[[6-[(3R)-3-aminopiperidin-1-yl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluoro-; 4-Fluoro-2-((6-((3R)-3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid; Alogliptin Process Impurity; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Impurity 12 is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. Long-term storage under inert atmosphere is recommended.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% 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.