Description

Alogliptin Impurity D is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the antidiabetic drug Alogliptin, ensuring the safety and efficacy of the final pharmaceutical product. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality assurance units for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Alogliptin drug substance and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Alogliptin to track impurity formation over time and under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Alogliptin.

Basic Information

Product Name	Alogliptin Impurity D
CAS No.	1926163-25-8
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 D; Alogliptin EP Impurity D; Alogliptin USP Impurity D; SYR-322 Impurity D; UNII-7QK1S4B66R
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Impurity D is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters as per ICH Q3A/B and relevant pharmacopeial (USP, EP) 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
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.