LOAD MORE
You're viewed all 11 products
Rotigotine
References
FAQ's
References
- Banfi, Aldo; Belogi, Gianluca; Fuganti, Claudio; Pizzocaro, Roberta, A Process for The Preparation Of Rotigotine, Fidia Farmaceutici S.p.A., Italy, WO2010035111A1, April 1, 2010
- Chu, Bao-Lin; Guo, Baoyuan; Zuo, Hongjian; Wang, Zhihua; Lin, Jin-Ming, Simultaneous enantioseparation of antiparkinsonian medication rotigotine and related chiral impurities by capillary zone electrophoresis using dual cyclodextrin system, Journal of Pharmaceutical and Biomedical Analysis, Volume: 46, Issue: 5, Pages: 854-859, 2008
Frequently Asked Questions
How are Rotigotine impurities detected and quantified?
Analytical methods, such as high-performance liquid chromatography (HPLC), are commonly used to detect and quantify impurities in Rotigotine batches. HPLC coupled with a UV detector offers excellent sensitivity and selectivity, allowing for their separation and identification in the drug.
How are specifications determined for Rotigotine impurities?
Impurity specifications for Rotigotine are through rigorous research, analysis, and regulatory considerations. Factors such as toxicological studies, clinical data, and regulatory guidelines help define acceptable limits for impurity levels. These specifications ensure that the drug remains safe and effective for patients.
What are the chromatographic methods for chiral separation of Rotigotine Impurities?
Direct chromatographic methods involve the chiral stationary phases that directly interact with the Rotigotine impurities, separating them based on their unique properties. Indirect chromatographic methods, on the other hand, rely on adding a chiral auxiliary or derivatization step to the Rotigotine molecule to introduce chiral selectivity for separation.
What are the temperature conditions required to store Rotigotine impurities?
Rotigotine impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).
Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.