Description

Alogliptin Impurity CAS NO 60271-06-9 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, quantification, and control of process-related impurities during the synthesis of Alogliptin, a leading anti-diabetic drug. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments to ensure drug safety, efficacy, and compliance with stringent global pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Alogliptin API (Active Pharmaceutical Ingredient) batches.
• Analytical Method Development & Validation: Used as a standard to develop, calibrate, and validate HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Critical for in-process testing and final release testing of Alogliptin to ensure it meets ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products in Alogliptin formulations under various stress conditions.
• Research & Development: Used by synthetic chemists to study reaction pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Product Name	Alogliptin Impurity
CAS No.	60271-06-9
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 Related Compound; Alogliptin Process Impurity; (R)-2-((6-(3-Aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile; Benzonitrile, 2-[[6-[(3R)-3-amino-1-piperidinyl]-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-
EINECS	Contact for details

Quality Control

Every batch of Alogliptin Impurity CAS 60271-06-9 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure identity, purity, and consistency, aligning with ICH guidelines and current Good Manufacturing Practices (cGMP). A comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic techniques is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.