Description

Alogliptin Benzoate Impurity K 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 (API) Alogliptin Benzoate by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance in drug development.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Alogliptin Benzoate API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for pharmaceutical quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Alogliptin formulations.
• Essential material for regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of synthetic routes and purification processes for Alogliptin Benzoate.
• Utilized in pharmacopeial testing to ensure batch-to-batch consistency and compliance with USP/EP monographs.

Basic Information

Product Name	Alogliptin Benzoate Impurity K
CAS No.	1618644-32-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile Benzoate; Alogliptin Related Compound K; SYR-322 Impurity K; TAK-875 Impurity K; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile Benzoate
EINECS	Contact for details

Quality Control

Our Alogliptin Benzoate Impurity K is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, NMR, and elemental analysis. A detailed Certificate of Analysis (COA) is provided, confirming identity, purity, and traceability. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines (Q3A, Q3B) on impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C (59-77°F). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.