Shelf lives of aseptically prepared medicines--stability of netilmicin injection in polypropylene syringes.
Identifieur interne : 004192 ( Main/Exploration ); précédent : 004191; suivant : 004193Shelf lives of aseptically prepared medicines--stability of netilmicin injection in polypropylene syringes.
Auteurs : Diane Clare Rigge [Royaume-Uni] ; Martin Frederick JonesSource :
- Journal of pharmaceutical and biomedical analysis [ 0731-7085 ] ; 2004.
Descripteurs français
- KwdFr :
- Antibactériens (administration et posologie), Antibactériens (analyse), Antibactériens (composition chimique), Asepsie (MeSH), Chromatographie en phase liquide à haute performance (MeSH), Nétilmicine (administration et posologie), Nétilmicine (analyse), Nétilmicine (composition chimique), Polypropylènes (MeSH), Reproductibilité des résultats (MeSH), Sensibilité et spécificité (MeSH), Seringues (MeSH), Stabilité de médicament (MeSH), Stockage de médicament (MeSH), Température (MeSH).
- MESH :
- administration et posologie : Antibactériens, Nétilmicine.
- analyse : Antibactériens, Nétilmicine.
- composition chimique : Antibactériens, Nétilmicine.
- Asepsie, Chromatographie en phase liquide à haute performance, Polypropylènes, Reproductibilité des résultats, Sensibilité et spécificité, Seringues, Stabilité de médicament, Stockage de médicament, Température.
English descriptors
- KwdEn :
- Anti-Bacterial Agents (administration & dosage), Anti-Bacterial Agents (analysis), Anti-Bacterial Agents (chemistry), Asepsis (MeSH), Chromatography, High Pressure Liquid (MeSH), Drug Stability (MeSH), Drug Storage (MeSH), Netilmicin (administration & dosage), Netilmicin (analysis), Netilmicin (chemistry), Polypropylenes (MeSH), Reproducibility of Results (MeSH), Sensitivity and Specificity (MeSH), Syringes (MeSH), Temperature (MeSH).
- MESH :
- chemical , administration & dosage : Anti-Bacterial Agents, Netilmicin.
- chemical , analysis : Anti-Bacterial Agents, Netilmicin.
- chemical , chemistry : Anti-Bacterial Agents, Netilmicin.
- Asepsis, Chromatography, High Pressure Liquid, Drug Stability, Drug Storage, Polypropylenes, Reproducibility of Results, Sensitivity and Specificity, Syringes, Temperature.
Abstract
There is no published information on the stability of netilmicin solutions in prefilled syringes. The purpose of this study was to evaluate the stability of netilmicin in polypropylene syringes and to determine the optimum validated shelf life so that they may be prepared in bulk in appropriately licensed facilities. The syringes containing netilmicin 10 or 100mg/ml were stored at 7 degrees C, room temperature in the light (RTL) and 25 degrees C/60% relative humidity for up to 300 days. Netilmicin concentration was determined by reversed phase high performance liquid chromatography (RP-HPLC) of the isoindole derivative formed with o-phthalaldehyde (OPA). The shelf lives were calculated using the maximum rate method applied to the netilmicin analytical data. At 7 degrees C 10 and 100mg/ml solutions were stable for 90 days falling to 30 days at 25 degrees C and 60% RH. At RTL the 10mg/ml solution was stable for 9 days.
DOI: 10.1016/j.jpba.2004.03.019
PubMed: 15336369
Affiliations:
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Le document en format XML
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(MeSH)</term><term>Drug Stability (MeSH)</term><term>Drug Storage (MeSH)</term><term>Netilmicin (administration & dosage)</term><term>Netilmicin (analysis)</term><term>Netilmicin (chemistry)</term><term>Polypropylenes (MeSH)</term><term>Reproducibility of Results (MeSH)</term><term>Sensitivity and Specificity (MeSH)</term><term>Syringes (MeSH)</term><term>Temperature (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Antibactériens (administration et posologie)</term><term>Antibactériens (analyse)</term><term>Antibactériens (composition chimique)</term><term>Asepsie (MeSH)</term><term>Chromatographie en phase liquide à haute performance (MeSH)</term><term>Nétilmicine (administration et posologie)</term><term>Nétilmicine (analyse)</term><term>Nétilmicine (composition chimique)</term><term>Polypropylènes (MeSH)</term><term>Reproductibilité des résultats (MeSH)</term><term>Sensibilité et spécificité (MeSH)</term><term>Seringues (MeSH)</term><term>Stabilité de médicament (MeSH)</term><term>Stockage de médicament (MeSH)</term><term>Température (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Netilmicin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Netilmicin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Netilmicin</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antibactériens</term><term>Nétilmicine</term></keywords><keywords scheme="MESH" qualifier="analyse" xml:lang="fr"><term>Antibactériens</term><term>Nétilmicine</term></keywords><keywords scheme="MESH" qualifier="composition chimique" xml:lang="fr"><term>Antibactériens</term><term>Nétilmicine</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Asepsis</term><term>Chromatography, High Pressure Liquid</term><term>Drug Stability</term><term>Drug Storage</term><term>Polypropylenes</term><term>Reproducibility of Results</term><term>Sensitivity and Specificity</term><term>Syringes</term><term>Temperature</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Asepsie</term><term>Chromatographie en phase liquide à haute performance</term><term>Polypropylènes</term><term>Reproductibilité des résultats</term><term>Sensibilité et spécificité</term><term>Seringues</term><term>Stabilité de médicament</term><term>Stockage de médicament</term><term>Température</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">There is no published information on the stability of netilmicin solutions in prefilled syringes. The purpose of this study was to evaluate the stability of netilmicin in polypropylene syringes and to determine the optimum validated shelf life so that they may be prepared in bulk in appropriately licensed facilities. The syringes containing netilmicin 10 or 100mg/ml were stored at 7 degrees C, room temperature in the light (RTL) and 25 degrees C/60% relative humidity for up to 300 days. Netilmicin concentration was determined by reversed phase high performance liquid chromatography (RP-HPLC) of the isoindole derivative formed with o-phthalaldehyde (OPA). The shelf lives were calculated using the maximum rate method applied to the netilmicin analytical data. At 7 degrees C 10 and 100mg/ml solutions were stable for 90 days falling to 30 days at 25 degrees C and 60% RH. At RTL the 10mg/ml solution was stable for 9 days.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">15336369</PMID><DateCompleted><Year>2005</Year><Month>03</Month><Day>01</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0731-7085</ISSN><JournalIssue CitedMedium="Print"><Volume>35</Volume><Issue>5</Issue><PubDate><Year>2004</Year><Month>Sep</Month><Day>03</Day></PubDate></JournalIssue><Title>Journal of pharmaceutical and biomedical analysis</Title><ISOAbbreviation>J Pharm Biomed Anal</ISOAbbreviation></Journal><ArticleTitle>Shelf lives of aseptically prepared medicines--stability of netilmicin injection in polypropylene syringes.</ArticleTitle><Pagination><MedlinePgn>1251-6</MedlinePgn></Pagination><Abstract><AbstractText>There is no published information on the stability of netilmicin solutions in prefilled syringes. The purpose of this study was to evaluate the stability of netilmicin in polypropylene syringes and to determine the optimum validated shelf life so that they may be prepared in bulk in appropriately licensed facilities. The syringes containing netilmicin 10 or 100mg/ml were stored at 7 degrees C, room temperature in the light (RTL) and 25 degrees C/60% relative humidity for up to 300 days. Netilmicin concentration was determined by reversed phase high performance liquid chromatography (RP-HPLC) of the isoindole derivative formed with o-phthalaldehyde (OPA). The shelf lives were calculated using the maximum rate method applied to the netilmicin analytical data. At 7 degrees C 10 and 100mg/ml solutions were stable for 90 days falling to 30 days at 25 degrees C and 60% RH. At RTL the 10mg/ml solution was stable for 9 days.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rigge</LastName><ForeName>Diane Clare</ForeName><Initials>DC</Initials><AffiliationInfo><Affiliation>Quality Control North West, Stepping Hill Hospital, Poplar Grove, Stockport, Cheshire SK2 7JE, UK. diane.rigge@stockport-tr.nwest.nhs.uk</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jones</LastName><ForeName>Martin Frederick</ForeName><Initials>MF</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Pharm Biomed Anal</MedlineTA><NlmUniqueID>8309336</NlmUniqueID><ISSNLinking>0731-7085</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011126">Polypropylenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>4O5J85GJJB</RegistryNumber><NameOfSubstance UI="D009428">Netilmicin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000900" MajorTopicYN="N">Anti-Bacterial Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName><QualifierName UI="Q000737" MajorTopicYN="N">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001207" MajorTopicYN="N">Asepsis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002851" MajorTopicYN="N">Chromatography, High Pressure Liquid</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004355" MajorTopicYN="N">Drug Stability</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004356" MajorTopicYN="N">Drug Storage</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009428" MajorTopicYN="N">Netilmicin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000032" MajorTopicYN="N">analysis</QualifierName><QualifierName UI="Q000737" MajorTopicYN="Y">chemistry</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011126" MajorTopicYN="N">Polypropylenes</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015203" MajorTopicYN="N">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012680" MajorTopicYN="N">Sensitivity and Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013594" MajorTopicYN="N">Syringes</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013696" MajorTopicYN="N">Temperature</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2003</Year><Month>10</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2004</Year><Month>02</Month><Day>25</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2004</Year><Month>03</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2004</Year><Month>9</Month><Day>1</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2005</Year><Month>3</Month><Day>2</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2004</Year><Month>9</Month><Day>1</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">15336369</ArticleId><ArticleId IdType="doi">10.1016/j.jpba.2004.03.019</ArticleId><ArticleId IdType="pii">S0731708504001724</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Royaume-Uni</li></country></list><tree><noCountry><name sortKey="Jones, Martin Frederick" sort="Jones, Martin Frederick" uniqKey="Jones M" first="Martin Frederick" last="Jones">Martin Frederick Jones</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="Rigge, Diane Clare" sort="Rigge, Diane Clare" uniqKey="Rigge D" first="Diane Clare" last="Rigge">Diane Clare Rigge</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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