Product Information

• Product Code：S007083

• English Name：Sitagliptin Impurity 83

• English Alias：7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine

• CAS No.：2892260-32-9

• Molecular Formula：C?H?F?N?O

• Molecular Weight：221.14

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Sitagliptin impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in acetonitrile-water solution within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 83 in Sitagliptin API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors Impurity 83 formation during Sitagliptin synthesis, reducing generation by >50% by adjusting cyclization temperature (e.g., 60-70℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL).

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 3 minutes, with LOD of 0.002 ng/mL for trace impurity analysis.

• Formation Mechanism：Mainly formed during the nitrosation of triazolopyrazine rings. Optimizing the reaction solvent system (e.g., using DMF instead of methanol) and controlling nitrosating agent dosage inhibits its formation.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 168.3 μM against HepG2 cells (Sitagliptin IC??=12.5 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com




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