Description

Alogliptin Related Compound 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Alogliptin, a medication used in the treatment of type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Alogliptin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, ICH guidelines).
• Regulatory Submissions: Essential for providing impurity data in regulatory filings (e.g., FDA, EMA) to demonstrate product safety and meet ICH Q3A/B requirements.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Alogliptin formulations.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies in pharmaceutical R&D.

Basic Information

Product Name	Alogliptin Related Compound 18
CAS No.	1430222-09-5
Molecular Formula	C18H21FN6O2
Molecular Weight	372.40 g/mol
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)-4-fluorobenzonitrile; Alogliptin Impurity 18; Alogliptin EP Impurity G; Alogliptin Related Substance 18; SYR-322 Related Compound 18; (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 Related Compound 18 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your quality and regulatory requirements.

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.

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 unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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