Description

Alogliptin Impurity 14 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Alogliptin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Alogliptin.

Basic Information

Product Name	Alogliptin Impurity 14
CAS No.	2205979-07-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alogliptin Related Compound 14; Alogliptin EP Impurity 14; Alogliptin USP Impurity 14; 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)-4-fluorobenzonitrile; Benzonitrile, 2-[[6-[(3R)-3-amino-1-piperidinyl]-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluoro-; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
EINECS	Contact for details

Quality Control

Our Alogliptin Impurity 14 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every 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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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