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, according to the criteria of RESOLUÇÃO DE DIRETORIA COLEGIADA - RDC Nº 53, DE 04 DE DEZEMBRO DE 2015.
The set of rules below is considered in the application, according to the maximum daily dose entered, with automatic calculation and conversion of doses, in addition to the adoption of the criterion in force in the rule " whichever is less ".
|Maximum Daily Dose 1||Limits 2|
|Notification Limits||≤ 1g||0,1%|
|Identification Limits||< 1mg||1,0% or 5µg ATD, whichever is less|
|1mg-10mg||0,5% or 20µg ATD, whichever is less|
|> 10mg-2g||0,2% or 2mg ATD, whichever is less|
|Qualification Limits||< 10mg||1,0% or 50µg ATD, whichever is less|
|10mg-100mg||0,5% or 200µg ATD, whichever is less|
|> 100mg-2g||0,2% or 3mg ATD, whichever is less|
In the page how to use the tool there is a step by step guide.