Morinidazole Impurity(Iodide) NEW

Morinidazole Impurity(Iodide)

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

• Product Information

• Product Number: M035043A

• English Name: Morinidazole Impurity 43(Iodide)

• English Alias: mono(4-ethyl-4-(3-(1-ethyl-2-methyl-5-nitro-1H-imidazol-1-ium-1-yl)-2-hydroxypropyl)morpholin-4-ium) monoiodide

• CAS Number: None

• Molecular Formula: C₁₅H₂₈N₄O₄²⁺·I⁻

• Molecular Weight: 328.41 (cationic part); 126.91 (iodide ion)

• Advantages

• As an iodide impurity of Morinidazole, this compound has the following advantages:

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• Well-defined and distinct structure: A salt structure containing dicationic quaternary ammonium groups (imidazolium and morpholinium) and iodide ion, significantly different from the monosubstituted imidazole structure of Morinidazole. It can be accurately identified by techniques such as ion chromatography and LC-MS, providing a specific marker for impurity detection;

• High stability and traceability: The quaternary ammonium salt structure is stable under acidic conditions. As a product of excessive N-alkylation in Morinidazole synthesis, it directly reflects the reaction degree of alkylating agents (e.g., iodoethane), improving the accuracy of process tracing;

• High detection sensitivity: The strong polarity of iodide ion and positive charge of quaternary ammonium cations show significant response in ion chromatography with conductivity detection, enabling trace analysis, reducing detection difficulty and enhancing method applicability.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to identify and quantify Morinidazole Impurity 43(Iodide) in Morinidazole APIs, ensuring residual diquaternary ammonium salts from excessive N-alkylation meet quality standards;

• Synthesis process optimization: Reducing the formation of diquaternary ammonium salts by monitoring the impurity content and optimizing the dosage of alkylating reagents (e.g., controlling iodoethane ratio) and reaction time to improve main product yield;

• Reaction pathway analysis: Assisting in analyzing the competitive reaction pathways of N-alkylation in Morinidazole synthesis, providing data support for process parameter adjustment.

• Background Description

• Morinidazole is a nitroimidazole antibacterial agent used to treat anaerobic infections, with a structure containing a monosubstituted imidazole ring. During N-alkylation, excessive alkylation of both imidazole and morpholine rings followed by combination with iodide ion may generate diquaternary ammonium salt impurities such as mono(4-ethyl-4-(3-(1-ethyl-2-methyl-5-nitro-1H-imidazol-1-ium-1-yl)-2-hydroxypropyl)morpholin-4-ium) monoiodide. The presence of such impurities may affect drug purity and stability, making their control a key part of Morinidazole quality assurance.

• Research Status

• Current research focuses on:

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• Detection method optimization: Using ion chromatography-mass spectrometry (IC-MS) with selected ion monitoring optimized for the isotopic characteristic of iodide ion (¹²⁷I) to achieve trace detection of this impurity (detection limits up to ppb level);

• Alkylation process improvement: Developing stepwise alkylation strategies to first selectively alkylate the imidazole ring and then modify the morpholine ring, reducing the probability of diquaternary ammonium salt formation;

• Dissociation behavior studies: Investigating the dissociation trend of this iodide impurity under high temperature and humidity conditions to evaluate its potential impact on the storage stability of Morinidazole formulations;

• Impurity limit setting: Establishing reasonable limits for this impurity based on toxicological evaluations and production consistency data, integrating it into the quality control system of Morinidazole.

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