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Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients
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SYSNO ASEP 0472554 Druh ASEP J - Článek v odborném periodiku Zařazení RIV J - Článek v odborném periodiku Poddruh J Článek ve WOS Název Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients Tvůrce(i) Pluháček, Tomáš (MBU-M) ORCID
Hanzal, J. (CZ)
Hendrych, J. (CZ)
Milde, D. (CZ)Zdroj.dok. Pharmazie. - : Avoxa - ISSN 0031-7144
Roč. 71, č. 4 (2016), s. 177-180Poč.str. 4 s. Jazyk dok. eng - angličtina Země vyd. DE - Německo Klíč. slova PLASMA-MASS SPECTROMETRY ; ICP-MS ; ELEMENTAL IMPURITIES Vědní obor RIV EE - Mikrobiologie, virologie Institucionální podpora MBU-M - RVO:61388971 UT WOS 000373966300003 EID SCOPUS 84970044287 DOI 10.1691/ph.2016.5140 Anotace The monitoring of inorganic impurities in active pharmaceutical ingredients plays a crucial role in the quality control of the pharmaceutical production. The heavy metals and residue on ignition/sulfated ash methods employing microwave-assisted digestion with concentrated nitric acid have been demonstrated as alternatives to inappropriate compendial methods recommended in United States Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.). The recoveries using the heavy metals method ranged between 89 % and 122 % for nearly all USP and Ph. Eur. restricted elements as well as the recoveries of sodium sulfate spikes were around 100 % in all tested matrices. The proposed microwave-assisted digestion method allowed simultaneous decomposition of 15 different active pharmaceutical ingredients with sample weigh up to 1 g. The heavy metals and sulfated ash procedures were successfully applied to the determination of heavy metals and residue on ignition/sulfated ash content in mycophenolate mofetil, nicergoline and silymarin.
KeywordsPracoviště Mikrobiologický ústav Kontakt Eliška Spurná, eliska.spurna@biomed.cas.cz, Tel.: 241 062 231 Rok sběru 2017
Počet záznamů: 1