The gravimetric method for the determination of residual moisture in freeze-dried biological products
Identifieur interne : 001785 ( Main/Exploration ); précédent : 001784; suivant : 001786The gravimetric method for the determination of residual moisture in freeze-dried biological products
Auteurs : Joan C. May [États-Unis] ; Roscoe M. Wheeler [États-Unis] ; Elizabeth Grim [États-Unis]Source :
- Cryobiology [ 0011-2240 ] ; 1988.
Abstract
The gravimetric test for the determination of residual moisture in freeze-dried biological products performed in a humidity- and temperature-controlled room with the use of scrupulous gravimetric analytical technique can be used to accurately determine residual moisture in freeze-dried biological products such as antihemophilic factor (human) or honey bee venom allergenic extract. This method determines the first water of hydration of sodium tartrate dihydrate (7.93%) to within 1.3% of the calculated value with a relative standard deviation of 0.3% for 10 replicates. For this gravimetric procedure, freeze-dried samples containing from 1.12 to 4.4% residual moisture had relative standard deviations ranging from 3.6 to 9.1%. Samples containing less than 1.0% residual moisture by the gravimetric method such as intravenous immune globulin and antihemophilic factor (human) had relative standard deviations ranging from 16.7 to 47.0%. Relative standard deviations for residual moisture tests performed on comparable samples by the Karl Fischer and thermogravimetric methods showed similar variability.
Url:
DOI: 10.1016/0011-2240(89)90023-0
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 001575
- to stream Istex, to step Curation: 001575
- to stream Istex, to step Checkpoint: 001296
- to stream Main, to step Merge: 001888
- to stream Main, to step Curation: 001785
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>The gravimetric method for the determination of residual moisture in freeze-dried biological products</title>
<author><name sortKey="May, Joan C" sort="May, Joan C" uniqKey="May J" first="Joan C." last="May">Joan C. May</name>
</author>
<author><name sortKey="Wheeler, Roscoe M" sort="Wheeler, Roscoe M" uniqKey="Wheeler R" first="Roscoe M." last="Wheeler">Roscoe M. Wheeler</name>
</author>
<author><name sortKey="Grim, Elizabeth" sort="Grim, Elizabeth" uniqKey="Grim E" first="Elizabeth" last="Grim">Elizabeth Grim</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:45CAC2F822D05459D5C80B36E35241C5BB0E9E96</idno>
<date when="1989" year="1989">1989</date>
<idno type="doi">10.1016/0011-2240(89)90023-0</idno>
<idno type="url">https://api.istex.fr/document/45CAC2F822D05459D5C80B36E35241C5BB0E9E96/fulltext/pdf</idno>
<idno type="wicri:Area/Istex/Corpus">001575</idno>
<idno type="wicri:Area/Istex/Curation">001575</idno>
<idno type="wicri:Area/Istex/Checkpoint">001296</idno>
<idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">001296</idno>
<idno type="wicri:doubleKey">0011-2240:1989:May J:the:gravimetric:method</idno>
<idno type="wicri:Area/Main/Merge">001888</idno>
<idno type="wicri:Area/Main/Curation">001785</idno>
<idno type="wicri:Area/Main/Exploration">001785</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title level="a">The gravimetric method for the determination of residual moisture in freeze-dried biological products</title>
<author><name sortKey="May, Joan C" sort="May, Joan C" uniqKey="May J" first="Joan C." last="May">Joan C. May</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Department of Health and Human Services, Public Health Service, Food and Drug Administration, HFB-740, Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Wheeler, Roscoe M" sort="Wheeler, Roscoe M" uniqKey="Wheeler R" first="Roscoe M." last="Wheeler">Roscoe M. Wheeler</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Department of Health and Human Services, Public Health Service, Food and Drug Administration, HFB-740, Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Grim, Elizabeth" sort="Grim, Elizabeth" uniqKey="Grim E" first="Elizabeth" last="Grim">Elizabeth Grim</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Department of Health and Human Services, Public Health Service, Food and Drug Administration, HFB-740, Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda</wicri:cityArea>
</affiliation>
</author>
</analytic>
<monogr></monogr>
<series><title level="j">Cryobiology</title>
<title level="j" type="abbrev">YCRYO</title>
<idno type="ISSN">0011-2240</idno>
<imprint><publisher>ELSEVIER</publisher>
<date type="published" when="1988">1988</date>
<biblScope unit="volume">26</biblScope>
<biblScope unit="issue">3</biblScope>
<biblScope unit="page" from="277">277</biblScope>
<biblScope unit="page" to="284">284</biblScope>
</imprint>
<idno type="ISSN">0011-2240</idno>
</series>
<idno type="istex">45CAC2F822D05459D5C80B36E35241C5BB0E9E96</idno>
<idno type="DOI">10.1016/0011-2240(89)90023-0</idno>
<idno type="PII">0011-2240(89)90023-0</idno>
</biblStruct>
</sourceDesc>
<seriesStmt><idno type="ISSN">0011-2240</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass></textClass>
<langUsage><language ident="en">en</language>
</langUsage>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">The gravimetric test for the determination of residual moisture in freeze-dried biological products performed in a humidity- and temperature-controlled room with the use of scrupulous gravimetric analytical technique can be used to accurately determine residual moisture in freeze-dried biological products such as antihemophilic factor (human) or honey bee venom allergenic extract. This method determines the first water of hydration of sodium tartrate dihydrate (7.93%) to within 1.3% of the calculated value with a relative standard deviation of 0.3% for 10 replicates. For this gravimetric procedure, freeze-dried samples containing from 1.12 to 4.4% residual moisture had relative standard deviations ranging from 3.6 to 9.1%. Samples containing less than 1.0% residual moisture by the gravimetric method such as intravenous immune globulin and antihemophilic factor (human) had relative standard deviations ranging from 16.7 to 47.0%. Relative standard deviations for residual moisture tests performed on comparable samples by the Karl Fischer and thermogravimetric methods showed similar variability.</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Maryland</li>
</region>
</list>
<tree><country name="États-Unis"><region name="Maryland"><name sortKey="May, Joan C" sort="May, Joan C" uniqKey="May J" first="Joan C." last="May">Joan C. May</name>
</region>
<name sortKey="Grim, Elizabeth" sort="Grim, Elizabeth" uniqKey="Grim E" first="Elizabeth" last="Grim">Elizabeth Grim</name>
<name sortKey="Wheeler, Roscoe M" sort="Wheeler, Roscoe M" uniqKey="Wheeler R" first="Roscoe M." last="Wheeler">Roscoe M. Wheeler</name>
</country>
</tree>
</affiliations>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Eau/explor/LotaV3/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001785 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001785 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Eau |area= LotaV3 |flux= Main |étape= Exploration |type= RBID |clé= ISTEX:45CAC2F822D05459D5C80B36E35241C5BB0E9E96 |texte= The gravimetric method for the determination of residual moisture in freeze-dried biological products }}
This area was generated with Dilib version V0.6.39. |