Description

Alogliptin Related Compound 5 (CAS NO 1338677-76-1) is a high-purity chemical reference standard critical for analytical research and quality control in pharmaceutical development. This compound serves as a key impurity marker for ensuring the purity and safety profile of the active pharmaceutical ingredient, Alogliptin. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality assurance laboratories for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify specific impurities in Alogliptin API and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to meet ICH Q2(R1) and USP guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC labs to establish acceptance criteria and ensure batch-to-batch consistency of Alogliptin.
• Stability Studies and Forced Degradation Studies: Acts as a benchmark to monitor the formation of degradation products under various stress conditions (heat, light, humidity).
• Regulatory Submissions and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA and EMA.
• Academic and Clinical Research: Supports pharmacokinetic, metabolic, and toxicological studies related to Alogliptin.

Basic Information

Product Name	Alogliptin Related Compound 5
CAS No.	1338677-76-1
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; Alogliptin Impurity 5; Alogliptin Related Substance 5; Alogliptin EP Impurity C; SYR-322 Related Compound 5; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
EINECS	Contact for details

Quality Control

Our Alogliptin Related Compound 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including high-performance liquid chromatography (HPLC) and spectroscopic identification, to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality systems support compliance with ICH Q7 guidelines for active pharmaceutical ingredients. Certificates are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.