Validação de método para determinação de resíduos de amoxicilina aplicado à validação de limpeza em indústria farmacêutica de penicilânicos Validation of a method for determination of amoxicillin residues applied to cleaning validation process in penicillins pharmaceutical industry
<abstract language="eng">The aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. Linearity was demonstrated between 2.5 and 17.5 μg/mL, without matrix effe...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Sociedade Brasileira de Química
2010-01-01
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| Series: | Química Nova |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422010000400038 |
| Summary: | <abstract language="eng">The aim of this work was the single-laboratory validation of a quantitative method for the determination of amoxicillin residues in support of cleaning control and validation. Linearity was demonstrated between 2.5 and 17.5 μg/mL, without matrix effects. Mean recoveries ranged from 84.00 to 103.74% and the relative standard deviation under repetitivity and within-reproducibility conditions were from 0.58 to 4.20% and from 0.79 to 4.39%, respectively. The theoretical limits of detection and quantification were 0.133 and 0.442 μg/mL, respectively. The studied method was suitable for cleaning control purpose within good manufacturing practices. |
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| ISSN: | 0100-4042 1678-7064 |