Itopride N-oxide is a derivative of itopride, an active pharmaceutical ingredient that has rapidly gained significance in the pharmaceutical sector. Itopride N-oxide is an impurity or a metabolite formed via the oxidative degradation of itopride. Today, itopride N-oxide is treated as a high-value purity, and it is applied during the development and validation of the analytical method. This article discusses the five ways in which itopride N-oxide is revolutionizing the chemical and pharmaceutical sectors. However, before diving into that, let’s understand basic information about itopride N-oxide.
As a leader in the high-purity chemical space, Advent is at the forefront of this revolution. With a focus on research-driven solutions, Advent not only provides premium-grade chemicals but also offers unparalleled expertise in impurity profiling and analytical method validation. Their work with itopride N-oxide exemplifies their commitment to driving industry innovation and ensuring that companies can meet the most stringent regulatory standards.
What is itopride N-oxide?
Itopride N-oxide is the product name used by most manufacturers. Its IUPAC name is 2-[4-[[(3,4-dimethoxybenzoyl)amino]methyl]phenoxy]-N, N-dimethylethanamine oxide and is usually denoted with the molecular formula C20H26N2O5, with the chemical abstracts service (CAS) number 141996-98-7. It has a molecular weight of 374.4 g and a monoisotopic mass of 374.184 g/mol.
How is itopride N-oxide revolutionizing the chemical sector?
It facilitates analytical method development and validation.
To successfully implement any pharmaceutical production or analysis process, it should first be validated to ensure it affords the necessary quality. Poor process validation results in inconsistent products, poor product quality, low efficiency, and raw material wastage. To avoid these disadvantages, itopride N-oxide is often used in analytical method development and validation experiments. It acts as a reliable standard to test the sensitivity, specificity, and accuracy of the analytical method.
Itopride N-oxide is often used to validate techniques such as high-performance liquid chromatography, 1H nuclear magnetic resonance spectroscopy, mass spectroscopy, and thermogravimetric analysis. By using it as a reference standard, researchers can tune the analytical procedures of these methods. Furthermore, reference standards of itopride N-oxide can also be used to calibrate instruments, which is employed by various pharmaceutical and chemical manufacturing companies. It allows these companies to maintain their product quality and avoid issues related to impurities, which can compromise drug safety.
Due to the versatility of itopride N-oxide, it can be used in various scales from nanograms to kilograms, depending entirely on the scope of the validation process. Owing to this scalability, itopride N-oxide is an excellent tool for research laboratories and pharmaceutical facilities.
It facilitates pharmaceutical impurity profiling.
Impurity profiling is crucial in the pharmaceutical industry because it ensures the safety and efficacy of drug formulations. Impurity profiling is also conducted by regulatory bodies like the United States Food and Drug Administration (USFDA) and the European Medicines Agency as part of their drug approval process.
Because itopride N-oxide is a known impurity and metabolite obtained during the oxidative degradation of itopride, the amount of itopride N-oxide produced is comprehensively analyzed. By providing comprehensive impurity characterization, pharma companies maintain their compliance with regulatory standards, ensuring no harmful degradation products are present in the final medication.
The complete characterization of itopride N-oxide also includes high-performance liquid chromatography, 1H nuclear magnetic resonance spectroscopy, mass spectroscopy, and thermogravimetric analysis. These characterization results can help the pharma company obtain the certificate of analysis, which enables them to sell the product in the market.
It is used in drug stability and degradation studies.
Stability and degradation studies are extremely important in pharmaceutical manufacturing because they help researchers understand how the product will function in different environments for different timelines. These studies are fundamental to understanding the long-term efficacy and safety of the pharmaceutical product. In these studies, metabolites or degradation products are tracked to determine whether the product is degrading via the expected pathway.
Because itopride N-oxide is a known metabolite of itopride, it can be used to study the degradation pathways of products containing itopride. By analyzing the formation of itopride N-oxide under different conditions, researchers can determine the stability of the parent formulation. This information can then be used to predict the shelf life, stability, and storage conditions of the parent formulation. If the results are not up to the mark, the formulation can be tuned and a similar process is followed. This improves the safety and quality of the final product that will be consumed by the patient.
It improves pharmaceutical manufacturing efficiency.
Pharmaceutical manufacturing requires comprehensive monitoring of all steps, raw materials, intermediates, and components. During this complex process, itopride N-oxide plays the role of a reference. Researchers can use the characterization data from itopride N-oxide to determine the efficiency of the pharmaceutical production process.
The ability to detect itopride N-oxide in itopride-based formulations helps manufacturers maintain a high level of purity and consistency across different manufacturing batches. Consequently, they can reduce the likelihood of batch rejections due to contamination or impurity-related issues, leading to cost savings and improved productivity. Because regulatory bodies demand rigorous quality assurance for all pharmaceutical products, having well-characterized impurities like itopride N-oxide helps companies maintain their compliance.
Consequently, during the manufacturing process, the quantity can be tracked to determine how many impurities are produced, which finally affords the amount of raw material wasted and the efficiency of the process.
It helps international standardization.
International standardization is complex but necessary because it ensures all products manufactured will be of high quality. It includes not only standardization of process in different facilities of the same company but also across different companies and countries.
Regulatory bodies can use the amount of itopride N-oxide produced to track the efficiency of manufacturing process and the quality of the final manufactured product. In turn, pharma companies around the world can use these values as standards to optimize their processes. This international standardization will result in improved product quality across the globe, allowing patients to access similar-quality and similar-efficiency products even when they are not within the reach of their local pharmacy.
Bottom Line
Itopride N-oxide, a chemical developed by Advent started as a degradation product, but it has started gaining considerable prominence in the pharmaceutical and chemical sectors. From facilitating stability tests to promoting international standardization, itopride N-oxide is reshaping the way companies approach impurity profiling, analytical method validation, and product quality control. As regulatory bodies implement stricter standards, companies can use this unique degradation product to improve their process efficiency and product quality.
Advent, a global leader in high-purity chemicals, continues to push the boundaries of innovation by offering solutions that align with the evolving needs of the industry. With a deep commitment to quality and compliance, Advent's pioneering work with Itopride N-oxide ensures that its clients remain ahead of the curve in meeting international regulatory requirements.
