Description

Alogliptin Related Compound 30 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 pharmaceutical products by serving as a benchmark in impurity identification and quantification. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the development and manufacturing of the antidiabetic drug Alogliptin.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Alogliptin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control and Assurance: Employed in routine batch testing within QC laboratories to monitor impurity levels and ensure compliance with strict regulatory specifications.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Alogliptin.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development: Utilized in synthetic chemistry research to study the metabolism, pharmacokinetics, and toxicological profile of related chemical structures.

Basic Information

Product Name	Alogliptin Related Compound 30
CAS No.	2276316-91-5
Molecular Formula	C18H21FN6O2
Molecular Weight	372.40 g/mol
Synonyms	Alogliptin Impurity 30; Alogliptin EP Impurity I; 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-; UNII-9K5J6QMF0F
EINECS	Contact for details

Quality Control

Our Alogliptin Related Compound 30 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity and purity meet exacting standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting all test results against predefined specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The product is hygroscopic (moisture-sensitive).

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
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.