Description

Sitagliptin Impurity 8 is a specified impurity and degradation product of the active pharmaceutical ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily used by analytical chemists, quality assurance professionals, and researchers in pharmaceutical companies and contract research organizations (CROs) for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Sitagliptin Impurity 8 in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Process Chemistry Research: Aids in understanding the degradation pathways and synthesis by-products of Sitagliptin, helping to optimize manufacturing processes.

Basic Information

Product Name	Sitagliptin Impurity 8
CAS No.	486460-22-4
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 g/mol
Synonyms	(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one; 1-[[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]amino]-3-(trifluoromethyl)-5,6-dihydro-8H-[1,2,4]triazolo[4,3-a]pyrazine; Sitagliptin Related Compound H; Januvia Impurity 8; MK-0431 Impurity 8; Sitagliptin EP Impurity H; Sitagliptin USP Related Compound H
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with cGMP and ICH Q3A/B guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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