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

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, compliant with EP (European Pharmacopoeia) impurity standards for Rizatriptan quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in aqueous solution (pH 4-6) within 6 months.

Applications

• Quality Control Testing：Used for HPLC and LC-MS detection of EP Impurity A in Rizatriptan API and formulations, controlling content to meet EP standards (≤0.1%).

• Process Optimization Research：Monitors impurity formation during Rizatriptan synthesis, reducing generation by >50% by adjusting condensation temperature (e.g., 80-90℃) and reaction time.

• Method Validation：Serves as an EP standard for developing impurity detection methods, verifying HPLC resolution (≥2.5) and LOD (0.01 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 4 minutes, with LOD of 0.003 ng/mL for EP-compliant trace analysis.

• Formation Mechanism：Formed by reaction of 3-(2-(dimethylamino)ethyl)-5-methylindole with 1,2,4-triazolylmethyl halide under alkaline conditions (e.g., potassium carbonate catalysis); optimizing catalyst dosage and solvent polarity (e.g., DMF-water system) inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 186.5 μM against SH-SY5Y cells (Rizatriptan IC₅₀=12.3 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing to monitor degradation under different pH 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!

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E-mail: anna@molcoo.com

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