Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61388971%3A_____%2F16%3A00472554" target="_blank" >RIV/61388971:_____/16:00472554 - isvavai.cz</a>

Alternative codes found

RIV/61989592:15310/16:33161055

Result on the web

<a href="http://dx.doi.org/10.1691/ph.2016.5140" target="_blank" >http://dx.doi.org/10.1691/ph.2016.5140</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1691/ph.2016.5140" target="_blank" >10.1691/ph.2016.5140</a>

Result language

angličtina

Original language name

Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients

Original language description

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.nKeywords

Czech name

—

Czech description

—

Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

EE - Microbiology, virology

OECD FORD branch

—

Project

<a href="/en/project/LO1305" target="_blank" >LO1305: Development of the center of advanced technologies and materials</a><br>

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2016

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Pharmazie

ISSN

0031-7144

e-ISSN

—

Volume of the periodical

71

Issue of the periodical within the volume

4

Country of publishing house

DE - GERMANY

Number of pages

4

Pages from-to

177-180

UT code for WoS article

000373966300003

EID of the result in the Scopus database

2-s2.0-84970044287