Description

Alogliptin Impurity B is a specified impurity of the active pharmaceutical ingredient Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes. This impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily used by analytical laboratories and quality control departments in the pharmaceutical industry for method development, validation, and as a reference standard in impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Alogliptin drug substances and products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to detect and quantify this specific impurity.
• Quality Control and Assurance: Serves as a benchmark in routine QC testing to ensure impurity levels in active pharmaceutical ingredients (APIs) and finished dosage forms remain within ICH-specified limits.
• Stability Studies: Employed to monitor the formation of degradation products in Alogliptin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in R&D to study the synthesis pathways, degradation mechanisms, and toxicological profiles of Alogliptin-related compounds.

Basic Information

Product Name	Alogliptin Impurity B
CAS No.	865758-98-1
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 B; Alogliptin EP Impurity B; Alogliptin USP Impurity B; SYR-322 Impurity B; 865758-98-1
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Impurity B is manufactured under strict quality management systems and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, MS, and NMR to meet the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specifications and traceability to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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