Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62157124%3A16370%2F15%3A43873855" target="_blank" >RIV/62157124:16370/15:43873855 - isvavai.cz</a>
Výsledek na webu
<a href="http://dx.doi.org/10.1155/2015/847349" target="_blank" >http://dx.doi.org/10.1155/2015/847349</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1155/2015/847349" target="_blank" >10.1155/2015/847349</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Popis výsledku v původním jazyce
Standard cleaning procedures of production line equipment were verified after manufacture of cytostatic injections containing Anthracycline derivate substance. Residual content of Anthracycline drug substance on stainless-steel equipment surface was determined using swab sampling with a specific HPLC-DAD analysis. The acceptance limit was decided as 200.0 mu g/100 cm(2). Recovery from the stainless-steel surface was 90.1%. Linearity of the method was observed in the concentration range of 0.155-194 mu g/mL when estimated using Zorbax TMS (5 mu m, 0.25 m x 4.6 mm ID) column at 1.3 mL/min flow rate and 254 nm (DAD 190-600 nm). The mobile phase consisted of lauryl hydrogen sulphate solution (3.7 g/L) : methanol : acetonitrile (54 : 16 : 30, v/v/v) with pHadjusted to 2.5 using phosphoric acid (85%). The LOD and LOQ for Anthracycline derivate were found to be 0.047 and 0.155 mu g/mL, respectively. The method validation confirmed the method provides acceptable degree of selectivity, lineari
Název v anglickém jazyce
Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Popis výsledku anglicky
Standard cleaning procedures of production line equipment were verified after manufacture of cytostatic injections containing Anthracycline derivate substance. Residual content of Anthracycline drug substance on stainless-steel equipment surface was determined using swab sampling with a specific HPLC-DAD analysis. The acceptance limit was decided as 200.0 mu g/100 cm(2). Recovery from the stainless-steel surface was 90.1%. Linearity of the method was observed in the concentration range of 0.155-194 mu g/mL when estimated using Zorbax TMS (5 mu m, 0.25 m x 4.6 mm ID) column at 1.3 mL/min flow rate and 254 nm (DAD 190-600 nm). The mobile phase consisted of lauryl hydrogen sulphate solution (3.7 g/L) : methanol : acetonitrile (54 : 16 : 30, v/v/v) with pHadjusted to 2.5 using phosphoric acid (85%). The LOD and LOQ for Anthracycline derivate were found to be 0.047 and 0.155 mu g/mL, respectively. The method validation confirmed the method provides acceptable degree of selectivity, lineari
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FR - Farmakologie a lékárnická chemie
OECD FORD obor
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Návaznosti výsledku
Projekt
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Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2015
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Journal of Spectroscopy
ISSN
2314-4920
e-ISSN
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Svazek periodika
Neuveden
Číslo periodika v rámci svazku
2015
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
8
Strana od-do
"Nestránkováno"
Kód UT WoS článku
000358619300001
EID výsledku v databázi Scopus
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