Rizatriptan EP Impurity A(Dihydrochloride)
Product Code：R047002A
English Name：Rizatriptan EP Impurity A(Dihydrochloride)
English Alias：2-(5-((1H-1,2,4-triazol-1-yl)methyl)-2-((3-(2-(dimethylamino)ethyl)-1H-indol-5-yl)methyl)-1H-indol-3-yl)-N,N-dimethylethanamine dihydrochloride
CAS No.：[Not Available]
Molecular Formula：C₂₈H₃₅N₇·2HCl
Molecular Weight：542.54（469.62 + 2×36.46）
Ultra-High Purity：Confirmed by HPLC (≥99.5%), combined with NMR (1H, 13C), HRMS, and elemental analysis, ensuring accuracy and reliability in impurity analysis.
Excellent Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.1% in acetonitrile-water (1:1) solution within 6 months, ensuring high reproducibility of experimental data.
Quality Control Testing：Used for UPLC-MS/MS detection of EP Impurity A (dihydrochloride) in Rizatriptan API and formulations, controlling impurity content to meet EP standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors the formation pathway of this impurity during Rizatriptan synthesis, reducing generation by over 50% by adjusting condensation reaction temperature (e.g., 80-90℃) 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).
Rizatriptan, a 5-hydroxytryptamine receptor agonist, is used for treating migraines. Impurity A (dihydrochloride), as an EP-specified impurity of Rizatriptan, may be generated during multi-step synthesis due to incomplete alkylation of the indole ring or connection of the triazole ring. Its complex bis-indole structure and dimethylamino group may affect drug stability and safety. With the stricter control requirements of EMA for European Pharmacopoeia impurities, the study of this impurity has become a key link in drug registration and production.
Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with an LOD of 0.002 ng/mL, meeting the needs of trace analysis.
Formation Mechanism：Studies have shown that this impurity is formed by the reaction of 3-(2-dimethylaminoethyl)indole with 1,2,4-triazole methylation reagents under alkaline conditions (e.g., potassium carbonate catalysis). Optimizing the solvent system (such as using DMF instead of ethanol) can inhibit side reactions.
Safety Evaluation：In vitro cytotoxicity experiments show that the IC₅₀ of this impurity against SH-SY5Y cells is 189.3 μM (Rizatriptan IC₅₀ = 12.6 μM). Although less toxic than the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being conducted to monitor its degradation behavior.
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
NOTE！
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
NEW IN STOCK!
The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!
China
