Rimegepant Impurity (Dihydrochloride) NEW

Rimegepant Impurity (Dihydrochloride); 1373116-08-5

Product Information

• Product Code：R046084A

• English Name：Rimegepant Impurity 84(Dihydrochloride)

• English Alias：852627-75-9(free base); N³-(piperidin-4-yl)pyridine-2,3-diamine dihydrochloride

• CAS No.：1373116-08-5

• Molecular Formula：C₁₀H₁₆N₄·2HCl

• Molecular Weight：192.26 (free base) + 2×36.46 (hydrochloride)

Advantages

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

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

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 84 in Rimegepant API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors Impurity 84 formation during Rimegepant synthesis, reducing generation by >40% by adjusting condensation temperature (e.g., 60-70℃) and pH.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) 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 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by condensation of 2,3-diaminopyridine with 4-chloropiperidine under alkaline conditions (e.g., triethylamine/DMF system) to give the free base, followed by salification with hydrochloric acid. Optimizing reaction time and hydrochloric acid dosage inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 185.3 μM against HEK293 cells (Rimegepant IC₅₀=8.7 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 and light conditions.

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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