I-Topilene ® i-R530A yi-polypropylene random copolymer eyenzelwe ngokukodwa ebonisa ubuchule obugqwesileyo benkqubo kunye nokucaca okulungileyo. Ifanelekile kwimveliso yamachiza, izimonyo kunye nokutya. I-Topilene ® R530A ihambelana neemfuno ze-FDA kwikhowudi ye-Federal Regulations kwi-21 CFR 177.1520 yoqhagamshelwano lokutya. Le mveliso iphumelele uvavanyo lwe-US Pharmacopoeia (i-USP iklasi Ⅵ) kunye novavanyo lwe-European Pharmacopoeia (EP 3.1.6) kwaye lunokusetyenziswa njengenjongo yonyango. Le mveliso ikwafumene imvume yoLawulo lokuTya kunye neDrugs yaseTshayina kwaye ibhaliswe kuluhlu lweFayile eyiNtloko yeziyobisi ye-FDA. (DMF No. 21499).