Description

Sitagliptin Impurity 5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Sitagliptin, a key medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Sitagliptin batches meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurity thresholds.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Supports synthetic route optimization and process chemistry research to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Sitagliptin Impurity 5
CAS No.	1879926-11-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R)-3-Hydroxy-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-2-one; (R)-3-Hydroxy-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-2-one; Sitagliptin Related Compound; Januvia Impurity; MK-0431 Impurity
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 5 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, spectroscopic identification (IR, NMR, MS), and residual solvent analysis, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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