Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Determination of Anthracycline Drug Residual in Cleaning Validation Swabs of Stainless-Steel Equipment after Production of Cytostatic Injections Using HPLC Analytical Method
Original language description
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
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FR - Pharmacology and apothecary chemistry
OECD FORD branch
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Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2015
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Spectroscopy
ISSN
2314-4920
e-ISSN
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Volume of the periodical
Neuveden
Issue of the periodical within the volume
2015
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
"Nestránkováno"
UT code for WoS article
000358619300001
EID of the result in the Scopus database
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