Prucalopride Nitroso Impurity 17(Formate)
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E-mail: anna@molcoo.com
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)
As the nitroso impurity 17 of Prucalopride (in formate form), this compound has the following 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.
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.
Prucalopride contains a piperidine ring, synthesized via piperidine amination. If the piperidine amino group is exposed to nitrous acid (e.g., from nitrate conversion) during production or storage, it may undergo nitrosation to form 1-nitrosopiperidin-4-amine. Its formate form, widely used as a reference due to stability and solubility advantages, is Prucalopride Nitroso Impurity 17(Formate). Due to potential genotoxicity and carcinogenicity of nitrosamines, their residues impact prucalopride safety, making detection and control critical for quality assurance.
Current research focuses on:
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
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