Description

Alogliptin Impurity C is a specified, structurally characterized impurity used in the quality control and regulatory compliance of the antidiabetic drug Alogliptin. This high-purity reference standard is critical for pharmaceutical manufacturers to ensure product safety, efficacy, and adherence to stringent ICH guidelines. It is primarily required by analytical laboratories and R&D departments for method development, validation, and routine batch release testing in the pharmaceutical industry.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Alogliptin drug substance and drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor impurity levels throughout the product lifecycle.
• Used in regulatory submissions (e.g., ANDA, NDA) to establish impurity thresholds and demonstrate compliance with ICH Q3A/B.
• Serves as a research tool in pharmacokinetic and metabolic studies to understand the degradation pathways of Alogliptin.
• Supports calibration and system suitability testing of chromatographic equipment in QC laboratories.

Basic Information

Product Name	Alogliptin Impurity C
CAS No.	1108731-49-2
Molecular Formula	C18H21N5O2
Molecular Weight	339.40 g/mol
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile; Alogliptin Related Compound C; SYR-322 Impurity C; TAK-875 Impurity C
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Impurity C is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with current Good Manufacturing Practice (cGMP) and ICH guidelines.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be sealed under an inert atmosphere if possible.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.