Rizatriptan EP Impurity A(Dihydrochloride) NEW

Rizatriptan EP Impurity A(Dihydrochloride)

Product Information

• 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）

Advantages

• 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.

Applications

• 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).

Background Description

Research Status

• 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

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