1A02820

2,5-Difluoro Sitagliptin

Pharmaceutical Analytical Impurity (PAI)

• 同義詞: ((3R)-3-Amino-4-(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]butan-1-one)
• 經驗公式（希爾表示法）: C₁₆H₁₆F₅N₅O
• CAS號碼: 486460-31-5
• 分子量：: 389.32
• 分類程式碼代碼: 41116100
• NACRES: NA.24

屬性

• 等級: pharmaceutical analytical impurity (PAI)
• agency: USP
• API 家族: sitagliptin
• 製造商／商標名: USP
• 應用: pharmaceutical
• 格式: neat
• 儲存溫度: 2-8°C

描述

一般說明

2,5-Difluoro Sitagliptin is a USP Pharmaceutical Analytical Impurity (PAI).

USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.

Associated Drug Substance: Sitagliptin.

For more information about this PAI, visit here.

應用

2,5-Difluoro Sitagliptin (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

特點和優勢

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.

分析報告

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.

其他說明

Sales restrictions may apply.

安全資訊

• 象形圖: GHS08,GHS07
• 訊號詞: Warning
• 危險聲明: H319,H373
• 防範說明: P260 - P264 - P280 - P305 + P351 + P338 - P314 - P337 + P313
• 危險分類: Eye Irrit. 2 - STOT RE 2
• 標靶器官: Liver
• 儲存類別代碼: 11 - Combustible Solids
• 水污染物質分類（WGK）: WGK 3
• 閃點（°F）: Not applicable
• 閃點（°C）: Not applicable