Description

Sitagliptin Impurity 34 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Sitagliptin, a widely prescribed medication for type 2 diabetes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug purity, safety, and regulatory compliance. The availability of this well-defined impurity standard is essential for method validation and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Sitagliptin Impurity 34 in Sitagliptin API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during stability studies.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that impurity levels in commercial batches of Sitagliptin are within International Council for Harmonisation (ICH) and pharmacopeial limits.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation studies.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during API synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Sitagliptin Impurity 34
CAS No.	945261-46-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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; Sitagliptin Related Compound 34; Januvia Impurity 34; MK-0431 Impurity 34; 1-[[(3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-[1,2,4]triazolo[4,3-a]pyrazine
EINECS	Contact for details

Quality Control

Our Sitagliptin Impurity 34 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the batch-specific results. We support compliance with cGMP standards for pharmaceutical impurities.

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 should be handled 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 matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.