Description

Sitagliptin Impurity CAS NO 1675201-14-5 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 quality control testing. The availability of this well-characterized impurity is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sitagliptin API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products in Sitagliptin under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Sitagliptin Impurity
CAS No.	1675201-14-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sitagliptin Related Compound; Januvia Impurity; (R)-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; MK-0431 Impurity; Sitagliptin EP Impurity; Sitagliptin USP Impurity; Desfluoro Sitagliptin Lactam Derivative
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity (CAS 1675201-14-5) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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

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