Description

Alogliptin Impurity 16 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antidiabetic drug Alogliptin through rigorous quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for compliance with stringent global pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Alogliptin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and level of this specific impurity during forced degradation and long-term stability studies of Alogliptin.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for Alogliptin manufacturing.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure Alogliptin drug substances and products meet specified purity criteria.

Basic Information

Product Name	Alogliptin Impurity 16
CAS No.	2203540-91-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alogliptin Related Compound 16; Alogliptin EP Impurity J; Alogliptin USP Impurity; 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile Impurity; Benzonitrile, 2-[[6-[(3R)-3-amino-1-piperidinyl]-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-; UNII-7F8F2F4V7H; Alogliptin Process Impurity; Alogliptin Degradant
EINECS	Contact for details

Quality Control

Our Alogliptin Impurity 16 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. We support compliance with ICH Q3A/B, USP, and EP guidelines, and our quality system is designed to meet the needs of cGMP manufacturing and regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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