Description

Sitagliptin Impurity 66 CAS NO 1283096-75-2 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Sitagliptin, a leading medication for type 2 diabetes. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during Sitagliptin API synthesis and purification processes.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating robust HPLC, UPLC, or LC-MS methods to ensure accurate impurity detection and quantification.
• Quality Control and Release Testing: Employed in routine QA/QC testing of Sitagliptin drug substances and finished drug products to confirm they meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Submission Support: Provides essential data for regulatory documentation (e.g., CMC sections of NDAs, ANDAs, MAAs) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Facilitates process chemistry optimization by helping scientists understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Sitagliptin Impurity 66
CAS No.	1283096-75-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(7R)-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; Sitagliptin Related Compound 66; Januvia Impurity 66; MK-0431 Impurity 66; DPP-4 Inhibitor Impurity; 1,2,4-Triazolo[4,3-a]pyrazine derivative
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 66 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques such as HPLC, GC, MS, NMR, and IR to ensure compliance with industry and client-specific standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.