RDC53 Mapping is a bonding application for impurities and degradation products. With this tool it is possible to evaluate which degradation products or impurities should be notified, identified and / or qualified. So it's informed the maximun daily dose of a drug, in miligrams, and then the degradation products and its concentration, by percentage, to evaluation.
The video above shows in a simples way how to use the tool. The step by step is described below. Access the mapping page by clicking here or in the tab "Map" at the page header.
This is a required field that requires a number value as input, representing the maximum dose of a drug in miligrams. This value will be used to calculate the total daily administration (ATD) of a degradation product, that will be informed after
There are a limit to inform up to ten degradation products information, and at least one is required. For each degradation product it's possible to give the product name and the concentration of it, giving a number as percentage.
After giving the product concentration, ATD will be calculated and shown in its fields.
By clicking on the "Point out obligations" button, results will appear, pointing if the product needs to be notified, qualified or identified. Also, a new button appear on the top of the page, saying "Export to Excel", that downloads an Excel sheet with the information that the page contains.