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Prucalopride
References
FAQ's
References
- Van Daele, Georges Henri Paul; Bosmans, Jean-Paul Rene Marie Andre; Schuurkes, Joannes Adrianus Jacobus, Enterokinetic Benzamide, Janssen Pharmaceutica N.V., Belgium, EP807110B1, May 8, 2002
- Vaibhavi N. Akhani, Mrs. Khushbu K. Patel, Ms. K. S. Patel, Dr. L.M. Prajapati and Dr. C. N. Patel, Development And Validation Of RP-HPLC Method For Estimation Of Prucalopride Succinate In Pharmaceutical Dosage Form, World Journal Of Pharmacy And Pharmaceutical Sciences, Volume 9, Issue 6, 1112-1122, 06 May 2020 DOI: 10.20959/wjpps20206-16234
Frequently Asked Questions
What are the permissible levels of Prucalopride impurities in pharmaceutical products?
The permissible levels of Prucalopride impurities in pharmaceutical products vary depending on regulatory guidelines and specific requirements. It is essential to comply with the established limits set by regulatory authorities to ensure the safety and quality of the drug.
How are Prucalopride impurities regulated throughout the production process?
Impurities in Prucalopride are regulated throughout the production process by implementing stringent quality control measures, rigorous analytical testing, and adherence to regulatory guidelines to ensure that impurity levels are within acceptable limits, thereby maintaining the safety and efficacy of the drug.
Is it possible that the presence of specific impurities may influence the stability of Prucalopride?
The presence of impurities in Prucalopride can impact its stability due to potential interactions or chemical reactions between the impurities and the active pharmaceutical ingredient.
What are the temperature conditions required to store Prucalopride impurities?
Prucalopride impurities are stored preferably at a regulated room temperature of 2-8°C or as specified on the Certificate of Analysis (CoA).
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