Prucalopride Nitroso Impurity 17(Formate) NEW

Prucalopride Nitroso Impurity 17(Formate)

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

Product Information

• Product Number: P037017A

• English Name: Prucalopride Nitroso Impurity 17(Formate)

• English Alias: 1-nitrosopiperidin-4-amine formate

• CAS Number: None

• Molecular Formula: C₅H₁₁N₃O·CH₂O₂

• Molecular Weight: 129.16 (free base); 46.03 (formate moiety)

Advantages

• Well-defined with distinct functional groups: Contains 1-nitrosopiperidin-4-amine core and formate structure. Unlike prucalopride (5-HT₄ receptor agonist with non-nitroso piperidine), its nitroso (-NO) polarity, piperidine basicity, and formate ionic bonding create significant differences, enabling precise differentiation via HPLC/ion-exchange chromatography as a specific marker;

• High stability and water solubility: Rigid piperidine structure and formate salt properties ensure high stability under acidic conditions, with superior water solubility over free base, facilitating dissolution in aqueous systems for accurate and reproducible analysis;

• High detection sensitivity: Conjugation between nitroso and piperidine shows characteristic UV absorption (230-260nm), combined with m/z 130 [M+H]⁺ (free base) enabling ppb-level analysis via LC-MS, compatible with 5-HT receptor agonist nitroso impurity systems.

Applications

• Pharmaceutical quality control: Used as an impurity reference standard to quantify Prucalopride Nitroso Impurity 17(Formate) in APIs, ensuring compliance with genotoxic impurity limits in pharmaceutical standards;

• Stability studies: Monitoring impurity levels under varying conditions (pH, light) to assess nitrosation trends and support safety assurance over shelf life;

• Synthesis assessment: Evaluating purity of piperidine-containing intermediates in prucalopride synthesis to reduce nitrosation risk at the source.

Background Description

Research Status

• Analytical method validation: Developing HPLC assays with C18 columns for separation, achieving 0.1 ppb detection limits;

• Nitrosation mechanism: Studying impurity formation kinetics under varying nitrite concentration and pH to clarify piperidine amino-to-nitroso derivative conversion pathways;

• Control strategies: Exploring nitrosation inhibitors (e.g., ascorbic acid) to keep impurity levels below safety limits (<0.001%);

• Structural confirmation: Using ¹H/¹³C-NMR and ion chromatography to verify formate structure, distinguishing from prucalopride for authoritative identification

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 17386083646
E-mail: anna@molcoo.com