Description

Sitagliptin n-Phoshate Impurity is a high-purity reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of drug products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical laboratories and quality assurance departments within the pharmaceutical industry, particularly those involved in the development and manufacturing of antidiabetic medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development and validation in impurity profiling.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (e.g., HPLC, UPLC) for the separation and detection of Sitagliptin-related impurities.
• Quality Control & Assurance: Employed as a system suitability test component and for the quantitative determination of this specific impurity in active pharmaceutical ingredient (API) batches to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used to monitor the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing the formation of this impurity during API synthesis.

Basic Information

Product Name	Sitagliptin n-Phoshate Impurity
CAS No.	1351498-25-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sitagliptin Phosphate Impurity; Sitagliptin Related Compound n-Phoshate; Januvia Impurity (Phosphate); (R)-4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-aminium Phosphate; MK-0431 Phosphate Impurity; DPP-4 Inhibitor Impurity; Antidiabetic Drug Impurity
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin n-Phoshate Impurity is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. We support compliance with ICH guidelines and 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). 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 desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
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.