Description

Sitagliptin Impurity 21 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of Sitagliptin, a leading anti-diabetic medication. This high-purity analytical standard is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of this specific impurity. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on analytical method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Sitagliptin Impurity 21 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles throughout the drug product lifecycle.
• Quality Control & Batch Release: Used in routine QA/QC testing to ensure Sitagliptin API and drug formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to identify and track the formation of this impurity under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability testing.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Sitagliptin synthesis, enabling process optimization and refinement to minimize its generation.

Basic Information

Product Name	Sitagliptin Impurity 21
CAS No.	2088771-60-0
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 g/mol
Synonyms	7-[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine; (R)-7-(3-Amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine; Sitagliptin Related Compound 21; Januvia Impurity 21; MK-0431 Impurity 21; DPP-4 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 21 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and establish purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results for purity, related substances, and residual solvents. Our quality standards are designed to support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed and stored in a desiccated area to prevent degradation due to moisture absorption.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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