Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

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: Example Local Codes - Drug - XML Representation

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="cs-local-codes-drug-pq-example"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">ionic-strength<a name="cs-local-codes-drug-pq-example-ionic-strength"> </a></td><td>Ionic Strength</td></tr><tr><td style="white-space:nowrap">physicochemical<a name="cs-local-codes-drug-pq-example-physicochemical"> </a></td><td>Physicochemical properties</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMW-15<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMW-15"> </a></td><td>SE-UHPLC HMW - 15</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMW-25<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMW-25"> </a></td><td>SE-UHPLC HMW - 25</td></tr><tr><td style="white-space:nowrap">SE-UHPLCMainPeak-15<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak-15"> </a></td><td>SE-UHPLC Main Peak - 15</td></tr><tr><td style="white-space:nowrap">SE-UHPLCMainPeak-25<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak-25"> </a></td><td>SE-UHPLC Main Peak - 25</td></tr><tr><td style="white-space:nowrap">SIZE<a name="cs-local-codes-drug-pq-example-SIZE"> </a></td><td>Particle Size</td></tr><tr><td style="white-space:nowrap">SOL<a name="cs-local-codes-drug-pq-example-SOL"> </a></td><td>Residual solvents</td></tr><tr><td style="white-space:nowrap">SOLV<a name="cs-local-codes-drug-pq-example-SOLV"> </a></td><td>Solvent</td></tr><tr><td style="white-space:nowrap">SSE<a name="cs-local-codes-drug-pq-example-SSE"> </a></td><td>Statistically significant effects</td></tr><tr><td style="white-space:nowrap">TEMP<a name="cs-local-codes-drug-pq-example-TEMP"> </a></td><td>Temperature</td></tr><tr><td style="white-space:nowrap">UCL<a name="cs-local-codes-drug-pq-example-UCL"> </a></td><td>Upper one-sided 95% confidence limit of Max Difference</td></tr><tr><td style="white-space:nowrap">uniformity-dosage<a name="cs-local-codes-drug-pq-example-uniformity-dosage"> </a></td><td>uniformity of dosage units (by weight)</td></tr><tr><td style="white-space:nowrap">WWWH<a name="cs-local-codes-drug-pq-example-WWWH"> </a></td><td>Water Content Homogeneity</td></tr><tr><td style="white-space:nowrap">SAMP<a name="cs-local-codes-drug-pq-example-SAMP"> </a></td><td>Number of Samples</td></tr><tr><td style="white-space:nowrap">DGP<a name="cs-local-codes-drug-pq-example-DGP"> </a></td><td>Degradation Products</td></tr><tr><td style="white-space:nowrap">DGP-s<a name="cs-local-codes-drug-pq-example-DGP-s"> </a></td><td>Drug Substance Related Organic impurities</td></tr><tr><td style="white-space:nowrap">IMP<a name="cs-local-codes-drug-pq-example-IMP"> </a></td><td>Impurity</td></tr><tr><td style="white-space:nowrap">Impurities<a name="cs-local-codes-drug-pq-example-Impurities"> </a></td><td>Impurities</td></tr><tr><td style="white-space:nowrap">WWW<a name="cs-local-codes-drug-pq-example-WWW"> </a></td><td>Water Content</td></tr><tr><td style="white-space:nowrap">Microbiological Quality<a name="cs-local-codes-drug-pq-example-MicrobiologicalQuality"> </a></td><td>Microbiological Quality</td></tr><tr><td style="white-space:nowrap">ASSAY<a name="cs-local-codes-drug-pq-example-ASSAY"> </a></td><td>Assay</td></tr><tr><td style="white-space:nowrap">CEX-HPLCAcidicPeak<a name="cs-local-codes-drug-pq-example-CEX-HPLCAcidicPeak"> </a></td><td>CEX-HPLC Acidic Peak</td></tr><tr><td style="white-space:nowrap">CEX-HPLCMainPeak<a name="cs-local-codes-drug-pq-example-CEX-HPLCMainPeak"> </a></td><td>CEX-HPLC Main Peak</td></tr><tr><td style="white-space:nowrap">PART<a name="cs-local-codes-drug-pq-example-PART"> </a></td><td>Particle size distribution</td></tr><tr><td style="white-space:nowrap">ASSH<a name="cs-local-codes-drug-pq-example-ASSH"> </a></td><td>Assay Content Homogeneity</td></tr><tr><td style="white-space:nowrap">DESC<a name="cs-local-codes-drug-pq-example-DESC"> </a></td><td>Description</td></tr><tr><td style="white-space:nowrap">Dissolution<a name="cs-local-codes-drug-pq-example-Dissolution"> </a></td><td>Dissolution</td></tr><tr><td style="white-space:nowrap">Dissolution Quantity<a name="cs-local-codes-drug-pq-example-DissolutionQuantity"> </a></td><td>Dissolution Quantity</td></tr><tr><td style="white-space:nowrap">ELE<a name="cs-local-codes-drug-pq-example-ELE"> </a></td><td>Elemental impurities</td></tr><tr><td style="white-space:nowrap">enantiomeric-purity<a name="cs-local-codes-drug-pq-example-enantiomeric-purity"> </a></td><td>Enantiomeric purity</td></tr><tr><td style="white-space:nowrap">IDT<a name="cs-local-codes-drug-pq-example-IDT"> </a></td><td>Identification</td></tr><tr><td style="white-space:nowrap">MUT<a name="cs-local-codes-drug-pq-example-MUT"> </a></td><td>Mutagenic impurities</td></tr><tr><td style="white-space:nowrap">NMR<a name="cs-local-codes-drug-pq-example-NMR"> </a></td><td>NMR</td></tr><tr><td style="white-space:nowrap">NMR-C<a name="cs-local-codes-drug-pq-example-NMR-C"> </a></td><td>NMR-C</td></tr><tr><td style="white-space:nowrap">NMR-H<a name="cs-local-codes-drug-pq-example-NMR-H"> </a></td><td>NMR-H</td></tr><tr><td style="white-space:nowrap">CEX-HPLCAcidicPeak-15<a name="cs-local-codes-drug-pq-example-CEX-HPLCAcidicPeak-15"> </a></td><td>CEX-HPLC Acidic Peak - 15</td></tr><tr><td style="white-space:nowrap">CEX-HPLCAcidicPeak-25<a name="cs-local-codes-drug-pq-example-CEX-HPLCAcidicPeak-25"> </a></td><td>CEX-HPLC Acidic Peak - 25</td></tr><tr><td style="white-space:nowrap">CEX-HPLCMainPeak-15<a name="cs-local-codes-drug-pq-example-CEX-HPLCMainPeak-15"> </a></td><td>CEX-HPLC Main Peak - 15</td></tr><tr><td style="white-space:nowrap">CEX-HPLCMainPeak-25<a name="cs-local-codes-drug-pq-example-CEX-HPLCMainPeak-25"> </a></td><td>CEX-HPLC Main Peak - 25</td></tr><tr><td style="white-space:nowrap">Homogeneity<a name="cs-local-codes-drug-pq-example-Homogeneity"> </a></td><td>Homogeneity demonstrated</td></tr><tr><td style="white-space:nowrap">LCL<a name="cs-local-codes-drug-pq-example-LCL"> </a></td><td>Lower one-sided 95% confidence limit of Max Difference</td></tr><tr><td style="white-space:nowrap">LOC<a name="cs-local-codes-drug-pq-example-LOC"> </a></td><td>Number of Locations</td></tr><tr><td style="white-space:nowrap">PARTS<a name="cs-local-codes-drug-pq-example-PARTS"> </a></td><td>Particle size</td></tr><tr><td style="white-space:nowrap">POS<a name="cs-local-codes-drug-pq-example-POS"> </a></td><td>Structure Position</td></tr><tr><td style="white-space:nowrap">particle-size-distribution<a name="cs-local-codes-drug-pq-example-particle-size-distribution"> </a></td><td>Particle size distribution</td></tr><tr><td style="white-space:nowrap">Lyophilization Water Homogeneity<a name="cs-local-codes-drug-pq-example-LyophilizationWaterHomogeneity"> </a></td><td>Lyophilization Water Homogeneity</td></tr><tr><td style="white-space:nowrap">Lyophilization Assay Homogeneity<a name="cs-local-codes-drug-pq-example-LyophilizationAssayHomogeneity"> </a></td><td>Lyophilization Assay Homogeneity</td></tr><tr><td style="white-space:nowrap">Particle Size RSD<a name="cs-local-codes-drug-pq-example-ParticleSizeRSD"> </a></td><td>Particle Size RSD</td></tr><tr><td style="white-space:nowrap">Obscuration<a name="cs-local-codes-drug-pq-example-Obscuration"> </a></td><td>Obscuration</td></tr><tr><td style="white-space:nowrap">Refractive index<a name="cs-local-codes-drug-pq-example-Refractiveindex"> </a></td><td>Refractive index</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisCarbon<a name="cs-local-codes-drug-pq-example-ElementalAnalysisCarbon"> </a></td><td>Elemental Analysis Carbon (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisCarbonMass<a name="cs-local-codes-drug-pq-example-IonAnalysisCarbonMass"> </a></td><td>Ion Analysis Carbon - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisCarbonMassAccuracy<a name="cs-local-codes-drug-pq-example-IonAnalysisCarbonMassAccuracy"> </a></td><td>Ion Analysis Carbon - Mass Accuracy</td></tr><tr><td style="white-space:nowrap">IonAnalysisCarbon<a name="cs-local-codes-drug-pq-example-IonAnalysisCarbon"> </a></td><td>Ion Analysis Carbon (%)</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisHydrogen<a name="cs-local-codes-drug-pq-example-ElementalAnalysisHydrogen"> </a></td><td>Elemental Analysis Hydrogen (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisHydrogenMass<a name="cs-local-codes-drug-pq-example-IonAnalysisHydrogenMass"> </a></td><td>Ion Analysis Hydrogen - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisHydrogenMassAccuracy<a name="cs-local-codes-drug-pq-example-IonAnalysisHydrogenMassAccuracy"> </a></td><td>Ion Analysis Hydrogen - Mass Accuracy</td></tr><tr><td style="white-space:nowrap">IonAnalysisHydrogen<a name="cs-local-codes-drug-pq-example-IonAnalysisHydrogen"> </a></td><td>Ion Analysis Hydrogen (%)</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisNitrogen<a name="cs-local-codes-drug-pq-example-ElementalAnalysisNitrogen"> </a></td><td>Elemental Analysis Nitrogen (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisNitrogen<a name="cs-local-codes-drug-pq-example-IonAnalysisNitrogen"> </a></td><td>Ion Analysis Nitrogen (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisNitrogenMass<a name="cs-local-codes-drug-pq-example-IonAnalysisNitrogenMass"> </a></td><td>Ion Analysis Nitrogen - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisNitrogenMassAccuracy<a name="cs-local-codes-drug-pq-example-IonAnalysisNitrogenMassAccuracy"> </a></td><td>Ion Analysis Nitrogen - Mass Accuracy</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisFlourine<a name="cs-local-codes-drug-pq-example-ElementalAnalysisFlourine"> </a></td><td>Elemental Analysis Flourine (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisFlourine<a name="cs-local-codes-drug-pq-example-IonAnalysisFlourine"> </a></td><td>Ion Analysis Flourine (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisFlourineMass<a name="cs-local-codes-drug-pq-example-IonAnalysisFlourineMass"> </a></td><td>Ion Analysis Flourine - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisFlourineMassAccuracy<a name="cs-local-codes-drug-pq-example-IonAnalysisFlourineMassAccuracy"> </a></td><td>Ion Analysis Flourine - Mass Accuracy</td></tr><tr><td style="white-space:nowrap">Chemical Structure<a name="cs-local-codes-drug-pq-example-ChemicalStructure"> </a></td><td>Chemical Structure</td></tr><tr><td style="white-space:nowrap">Diffractogram<a name="cs-local-codes-drug-pq-example-Diffractogram"> </a></td><td>Diffractogram</td></tr><tr><td style="white-space:nowrap">MolecularStructure<a name="cs-local-codes-drug-pq-example-MolecularStructure"> </a></td><td>Molecular Structure</td></tr><tr><td style="white-space:nowrap">Absorption<a name="cs-local-codes-drug-pq-example-Absorption"> </a></td><td>Absorption</td></tr><tr><td style="white-space:nowrap">X-Ray Powder Diffractogram<a name="cs-local-codes-drug-pq-example-X-RayPowderDiffractogram"> </a></td><td>X-Ray Powder Diffractogram</td></tr><tr><td style="white-space:nowrap">pH (post-dilution bulk solution)<a name="cs-local-codes-drug-pq-example-pH.40post-dilutionbulksolution.41"> </a></td><td>pH (post-dilution bulk solution)</td></tr><tr><td style="white-space:nowrap">Appearance (Product Container, visual)<a name="cs-local-codes-drug-pq-example-Appearance.40ProductContainer.44visual.41"> </a></td><td>Appearance (Product Container, visual)</td></tr><tr><td style="white-space:nowrap">Appearance (Lyophilized, Visual)<a name="cs-local-codes-drug-pq-example-Appearance.40Lyophilized.44Visual.41"> </a></td><td>Appearance (Lyophilized, Visual)</td></tr><tr><td style="white-space:nowrap">Appearance (Reconstituted, Visual)<a name="cs-local-codes-drug-pq-example-Appearance.40Reconstituted.44Visual.41"> </a></td><td>Appearance (Reconstituted, Visual)</td></tr><tr><td style="white-space:nowrap">Appearance<a name="cs-local-codes-drug-pq-example-Appearance"> </a></td><td>Appearance</td></tr><tr><td style="white-space:nowrap">pH (reconstituted)<a name="cs-local-codes-drug-pq-example-pH.40reconstituted.41"> </a></td><td>pH (reconstituted)</td></tr><tr><td style="white-space:nowrap">TAMC<a name="cs-local-codes-drug-pq-example-TAMC"> </a></td><td>TAMC</td></tr><tr><td style="white-space:nowrap">Fill Weight Average<a name="cs-local-codes-drug-pq-example-FillWeightAverage"> </a></td><td>Fill Weight Average</td></tr><tr><td style="white-space:nowrap">Fill Weight Target (g)<a name="cs-local-codes-drug-pq-example-FillWeightTarget.40g.41"> </a></td><td>Fill Weight Target (g)</td></tr><tr><td style="white-space:nowrap">Actual Avg. Weight from Target<a name="cs-local-codes-drug-pq-example-ActualAvg.46WeightfromTarget"> </a></td><td>Actual Avg. Weight from Target</td></tr><tr><td style="white-space:nowrap">Hold Time (filtration To filling)<a name="cs-local-codes-drug-pq-example-HoldTime.40filtrationTofilling.41"> </a></td><td>Hold Time (filtration To filling)</td></tr><tr><td style="white-space:nowrap">Hold Time (start filling to end filling)<a name="cs-local-codes-drug-pq-example-HoldTime.40startfillingtoendfilling.41"> </a></td><td>Hold Time (start filling to end filling)</td></tr><tr><td style="white-space:nowrap">Filter Integrity Test<a name="cs-local-codes-drug-pq-example-FilterIntegrityTest"> </a></td><td>Filter Integrity Test</td></tr><tr><td style="white-space:nowrap">Lyophilizer Number<a name="cs-local-codes-drug-pq-example-LyophilizerNumber"> </a></td><td>Lyophilizer Number</td></tr><tr><td style="white-space:nowrap">pH (adjustment of pre-clarification bulk solution)<a name="cs-local-codes-drug-pq-example-pH.40adjustmentofpre-clarificationbulksolution.41"> </a></td><td>pH (adjustment of pre-clarification bulk solution)</td></tr><tr><td style="white-space:nowrap">Assay (pre-clarification filtration) (mg/mL)<a name="cs-local-codes-drug-pq-example-Assay.40pre-clarificationfiltration.41.40mg.47mL.41"> </a></td><td>Assay (pre-clarification filtration) (mg/mL)</td></tr><tr><td style="white-space:nowrap">Assay (Post dilution bulk solution) (mg/mL)<a name="cs-local-codes-drug-pq-example-Assay.40Postdilutionbulksolution.41.40mg.47mL.41"> </a></td><td>Assay (Post dilution bulk solution) (mg/mL)</td></tr><tr><td style="white-space:nowrap">Test Date<a name="cs-local-codes-drug-pq-example-TestDate"> </a></td><td>Test Date</td></tr><tr><td style="white-space:nowrap">Identification (NMR)<a name="cs-local-codes-drug-pq-example-Identification.40NMR.41"> </a></td><td>Identification (NMR)</td></tr><tr><td style="white-space:nowrap">Identification (FT-IR)<a name="cs-local-codes-drug-pq-example-Identification.40FT-IR.41"> </a></td><td>Identification (FT-IR)</td></tr><tr><td style="white-space:nowrap">VisualInspection<a name="cs-local-codes-drug-pq-example-VisualInspection"> </a></td><td>VisualInspection</td></tr><tr><td style="white-space:nowrap">InfraredSpectroscopy<a name="cs-local-codes-drug-pq-example-InfraredSpectroscopy"> </a></td><td>InfraredSpectroscopy</td></tr><tr><td style="white-space:nowrap">SupplierCertificateofAnalysis<a name="cs-local-codes-drug-pq-example-SupplierCertificateofAnalysis"> </a></td><td>SupplierCertificateofAnalysis</td></tr><tr><td style="white-space:nowrap">Elemental<a name="cs-local-codes-drug-pq-example-Elemental"> </a></td><td>Elemental</td></tr><tr><td style="white-space:nowrap">Uniformity of Dosage Units, Weight Variation<a name="cs-local-codes-drug-pq-example-UniformityofDosageUnits.44WeightVariation"> </a></td><td>Uniformity of Dosage Units, Weight Variation</td></tr><tr><td style="white-space:nowrap">Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)<a name="cs-local-codes-drug-pq-example-UniformityofDosageUnits.44WeightVariation-AcceptanceValue.40AV.41"> </a></td><td>Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)</td></tr><tr><td style="white-space:nowrap">Yield (%)<a name="cs-local-codes-drug-pq-example-Yield.40.37.41"> </a></td><td>Yield (%)</td></tr><tr><td style="white-space:nowrap">ResidualWaterContent<a name="cs-local-codes-drug-pq-example-ResidualWaterContent"> </a></td><td>Residual Water Content (w/w%)</td></tr><tr><td style="white-space:nowrap">Reaction conversion: Residual Starting Material 1 by HPLC<a name="cs-local-codes-drug-pq-example-Reactionconversion.58ResidualStartingMaterial1byHPLC"> </a></td><td>Reaction conversion: Residual Starting Material 1 by HPLC</td></tr><tr><td style="white-space:nowrap">Bacterial Endotoxins (EU/mL)<a name="cs-local-codes-drug-pq-example-BacterialEndotoxins.40EU.47mL.41"> </a></td><td>Bacterial Endotoxins (EU/mL)</td></tr><tr><td style="white-space:nowrap">Bioburden - Beginning<a name="cs-local-codes-drug-pq-example-Bioburden-Beginning"> </a></td><td>Bioburden - Beginning</td></tr><tr><td style="white-space:nowrap">Bioburden - End<a name="cs-local-codes-drug-pq-example-Bioburden-End"> </a></td><td>Bioburden - End</td></tr><tr><td style="white-space:nowrap">Bioburden (CFU/ 100 mL)<a name="cs-local-codes-drug-pq-example-Bioburden.40CFU.47100mL.41"> </a></td><td>Bioburden (CFU/ 100 mL)</td></tr><tr><td style="white-space:nowrap">Buffer vessel mixing speed (rpm)<a name="cs-local-codes-drug-pq-example-Buffervesselmixingspeed.40rpm.41"> </a></td><td>Buffer vessel mixing speed (rpm)</td></tr><tr><td style="white-space:nowrap">Buffer vessel mixing time (min)<a name="cs-local-codes-drug-pq-example-Buffervesselmixingtime.40min.41"> </a></td><td>Buffer vessel mixing time (min)</td></tr><tr><td style="white-space:nowrap">CONC<a name="cs-local-codes-drug-pq-example-CONC"> </a></td><td>Conclusion</td></tr><tr><td style="white-space:nowrap">Conductivity (μS/cm)<a name="cs-local-codes-drug-pq-example-Conductivity.40.956S.47cm.41"> </a></td><td>Conductivity (μS/cm)</td></tr><tr><td style="white-space:nowrap">Fill Weight<a name="cs-local-codes-drug-pq-example-FillWeight"> </a></td><td>Fill Weight</td></tr><tr><td style="white-space:nowrap">Fill Weight - Maximum<a name="cs-local-codes-drug-pq-example-FillWeight-Maximum"> </a></td><td>Fill Weight - Maximum</td></tr><tr><td style="white-space:nowrap">Fill Weight - Mean<a name="cs-local-codes-drug-pq-example-FillWeight-Mean"> </a></td><td>Fill Weight - Mean</td></tr><tr><td style="white-space:nowrap">Fill Weight - Minimum<a name="cs-local-codes-drug-pq-example-FillWeight-Minimum"> </a></td><td>Fill Weight - Minimum</td></tr><tr><td style="white-space:nowrap">FiltrationPressure (psig)<a name="cs-local-codes-drug-pq-example-FiltrationPressure.40psig.41"> </a></td><td>FiltrationPressure (psig)</td></tr><tr><td style="white-space:nowrap">Formulation vessel mixing speed (rpm)<a name="cs-local-codes-drug-pq-example-Formulationvesselmixingspeed.40rpm.41"> </a></td><td>Formulation vessel mixing speed (rpm)</td></tr><tr><td style="white-space:nowrap">Formulation vessel mixing time (min)<a name="cs-local-codes-drug-pq-example-Formulationvesselmixingtime.40min.41"> </a></td><td>Formulation vessel mixing time (min)</td></tr><tr><td style="white-space:nowrap">Growth Promotion - Beginning<a name="cs-local-codes-drug-pq-example-GrowthPromotion-Beginning"> </a></td><td>Growth Promotion - Beginning</td></tr><tr><td style="white-space:nowrap">Growth Promotion - End<a name="cs-local-codes-drug-pq-example-GrowthPromotion-End"> </a></td><td>Growth Promotion - End</td></tr><tr><td style="white-space:nowrap">GrowthPromotion<a name="cs-local-codes-drug-pq-example-GrowthPromotion"> </a></td><td>Growth Promotion</td></tr><tr><td style="white-space:nowrap">Hold Time<a name="cs-local-codes-drug-pq-example-HoldTime"> </a></td><td>Hold Time</td></tr><tr><td style="white-space:nowrap">LyophilizationHomogeneneity<a name="cs-local-codes-drug-pq-example-LyophilizationHomogeneneity"> </a></td><td>Lyophilization Homogeneneity</td></tr><tr><td style="white-space:nowrap">Media Challenge Hold Times<a name="cs-local-codes-drug-pq-example-MediaChallengeHoldTimes"> </a></td><td>Media Challenge Hold Times</td></tr><tr><td style="white-space:nowrap">MediaChallengeRun<a name="cs-local-codes-drug-pq-example-MediaChallengeRun"> </a></td><td>Media Challenge Run</td></tr><tr><td style="white-space:nowrap">Osmolality<a name="cs-local-codes-drug-pq-example-Osmolality"> </a></td><td>Osmolality</td></tr><tr><td style="white-space:nowrap">OVERALLSAMP<a name="cs-local-codes-drug-pq-example-OVERALLSAMP"> </a></td><td>Number of Samples</td></tr><tr><td style="white-space:nowrap">particle-size<a name="cs-local-codes-drug-pq-example-particle-size"> </a></td><td>Particle Size</td></tr><tr><td style="white-space:nowrap">pH<a name="cs-local-codes-drug-pq-example-pH"> </a></td><td>pH</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 (% w/v)<a name="cs-local-codes-drug-pq-example-Polysorbate80.40.37w.47v.41"> </a></td><td>Polysorbate 80 (% w/v)</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration - Beginning - Max<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration-Beginning-Max"> </a></td><td>Polysorbate 80 concentration - Beginning - Max</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration - Beginning - Min<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration-Beginning-Min"> </a></td><td>Polysorbate 80 concentration - Beginning - Min</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration - End - Max<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration-End-Max"> </a></td><td>Polysorbate 80 concentration - End - Max</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration - End - Min<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration-End-Min"> </a></td><td>Polysorbate 80 concentration - End - Min</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration - Middle - Max<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration-Middle-Max"> </a></td><td>Polysorbate 80 concentration - Middle - Max</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration - Middle - Min<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration-Middle-Min"> </a></td><td>Polysorbate 80 concentration - Middle - Min</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 concentration (% w/v)<a name="cs-local-codes-drug-pq-example-Polysorbate80concentration.40.37w.47v.41"> </a></td><td>Polysorbate 80 concentration (% w/v)</td></tr><tr><td style="white-space:nowrap">Post-filtration Filter Integrity (psig)<a name="cs-local-codes-drug-pq-example-Post-filtrationFilterIntegrity.40psig.41"> </a></td><td>Post-filtration Filter Integrity (psig)</td></tr><tr><td style="white-space:nowrap">Pre-filtration Bioburden (CFU/ 100 mL)<a name="cs-local-codes-drug-pq-example-Pre-filtrationBioburden.40CFU.47100mL.41"> </a></td><td>Pre-filtration Bioburden (CFU/ 100 mL)</td></tr><tr><td style="white-space:nowrap">Protein Concentration (mg/mL)<a name="cs-local-codes-drug-pq-example-ProteinConcentration.40mg.47mL.41"> </a></td><td>Protein Concentration (mg/mL)</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - End - Higher<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-End-Higher"> </a></td><td>Protein Concentration - Beginning - End - Higher</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - End - Lower<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-End-Lower"> </a></td><td>Protein Concentration - Beginning - End - Lower</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - End - Mean<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-End-Mean"> </a></td><td>Protein Concentration - Beginning - End - Mean</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - Max<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-Max"> </a></td><td>Protein Concentration - Beginning - Max</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - Middle - Higher<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-Middle-Higher"> </a></td><td>Protein Concentration - Beginning - Middle - Higher</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - Middle - Lower<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-Middle-Lower"> </a></td><td>Protein Concentration - Beginning - Middle - Lower</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - Middle - Mean<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-Middle-Mean"> </a></td><td>Protein Concentration - Beginning - Middle - Mean</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Beginning - Min<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Beginning-Min"> </a></td><td>Protein Concentration - Beginning - Min</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Conclusion<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Conclusion"> </a></td><td>Protein Concentration - Conclusion</td></tr><tr><td style="white-space:nowrap">Protein Concentration - End - Max<a name="cs-local-codes-drug-pq-example-ProteinConcentration-End-Max"> </a></td><td>Protein Concentration - End - Max</td></tr><tr><td style="white-space:nowrap">Protein Concentration - End - Min<a name="cs-local-codes-drug-pq-example-ProteinConcentration-End-Min"> </a></td><td>Protein Concentration - End - Min</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Middle - End - Higher<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Middle-End-Higher"> </a></td><td>Protein Concentration - Middle - End - Higher</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Middle - End - Lower<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Middle-End-Lower"> </a></td><td>Protein Concentration - Middle - End - Lower</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Middle - End - Mean<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Middle-End-Mean"> </a></td><td>Protein Concentration - Middle - End - Mean</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Middle - Max<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Middle-Max"> </a></td><td>Protein Concentration - Middle - Max</td></tr><tr><td style="white-space:nowrap">Protein Concentration - Middle - Min<a name="cs-local-codes-drug-pq-example-ProteinConcentration-Middle-Min"> </a></td><td>Protein Concentration - Middle - Min</td></tr><tr><td style="white-space:nowrap">Protein Concentration Statistics<a name="cs-local-codes-drug-pq-example-ProteinConcentrationStatistics"> </a></td><td>Protein Concentration Statistics</td></tr><tr><td style="white-space:nowrap">Residual Moisture - Max<a name="cs-local-codes-drug-pq-example-ResidualMoisture-Max"> </a></td><td>Residual Moisture - Max</td></tr><tr><td style="white-space:nowrap">Residual Moisture - Min<a name="cs-local-codes-drug-pq-example-ResidualMoisture-Min"> </a></td><td>Residual Moisture - Min</td></tr><tr><td style="white-space:nowrap">Residual Moisture<a name="cs-local-codes-drug-pq-example-ResidualMoisture"> </a></td><td>Residual Moisture</td></tr><tr><td style="white-space:nowrap">SE-UHPLC Main Peak - Beginning<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak-Beginning"> </a></td><td>SE-UHPLC Main Peak - Beginning</td></tr><tr><td style="white-space:nowrap">SE-UHPLC HMW - Conclusion<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMW-Conclusion"> </a></td><td>SE-UHPLC HMW - Conclusion</td></tr><tr><td style="white-space:nowrap">SE-UHPLC Main Peak - Conclusion<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak-Conclusion"> </a></td><td>SE-UHPLC Main Peak - Conclusion</td></tr><tr><td style="white-space:nowrap">SE-UHPLC Main Peak - End<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak-End"> </a></td><td>SE-UHPLC Main Peak - End</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMW - Beginning<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMW-Beginning"> </a></td><td>SE-UHPLC HMW - Beginning</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMW - End<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMW-End"> </a></td><td>SE-UHPLC HMW - End</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMWPeak - Conclusion<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMWPeak-Conclusion"> </a></td><td>SE-UHPLC HMW Peak - Conclusion</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMW<a name="cs-local-codes-drug-pq-example-SE-UHPLCHMW"> </a></td><td>SE-UHPLC HMW</td></tr><tr><td style="white-space:nowrap">SE-UHPLCMainPeak - Conclusion<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak-Conclusion"> </a></td><td>SE-UHPLC Main Peak - Conclusion</td></tr><tr><td style="white-space:nowrap">SE-UHPLCMainPeak<a name="cs-local-codes-drug-pq-example-SE-UHPLCMainPeak"> </a></td><td>SE-UHPLC Main Peak</td></tr><tr><td style="white-space:nowrap">test-success<a name="cs-local-codes-drug-pq-example-test-success"> </a></td><td>Test Success</td></tr><tr><td style="white-space:nowrap">Thaw Time<a name="cs-local-codes-drug-pq-example-ThawTime"> </a></td><td>Thaw Time</td></tr><tr><td style="white-space:nowrap">Thawing Temp<a name="cs-local-codes-drug-pq-example-ThawingTemp"> </a></td><td>Thawing Temp</td></tr><tr><td style="white-space:nowrap">WaterContent<a name="cs-local-codes-drug-pq-example-WaterContent"> </a></td><td>Water content</td></tr><tr><td style="white-space:nowrap">AssignedPurity<a name="cs-local-codes-drug-pq-example-AssignedPurity"> </a></td><td>Assigned Purity</td></tr><tr><td style="white-space:nowrap">1d2344<a name="cs-local-codes-drug-pq-example-1d2344"> </a></td><td>Tape</td></tr><tr><td style="white-space:nowrap">200000003208<a name="cs-local-codes-drug-pq-example-200000003208"> </a></td><td>Plastic</td></tr><tr><td style="white-space:nowrap">112344ss<a name="cs-local-codes-drug-pq-example-112344ss"> </a></td><td>PVC</td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.41.16.6"/>
  </identifier>
  <version value="1.0.0"/>
  <name value="CsLocalCodesDrugPQ"/>
  <title value="Example Local Codes - Drug"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-05-08T12:53:57+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International - Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <description
               value="This example code system contains temporary example codes used in pharmaceutical quality industry."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
    <text value="World"/>
  </jurisdiction>
  <caseSensitive value="true"/>
  <content value="complete"/>
  <concept>
    <code value="ionic-strength"/>
    <display value="Ionic Strength"/>
  </concept>
  <concept>
    <code value="physicochemical"/>
    <display value="Physicochemical properties"/>
  </concept>
  <concept>
    <code value="SE-UHPLCHMW-15"/>
    <display value="SE-UHPLC HMW - 15"/>
  </concept>
  <concept>
    <code value="SE-UHPLCHMW-25"/>
    <display value="SE-UHPLC HMW - 25"/>
  </concept>
  <concept>
    <code value="SE-UHPLCMainPeak-15"/>
    <display value="SE-UHPLC Main Peak - 15"/>
  </concept>
  <concept>
    <code value="SE-UHPLCMainPeak-25"/>
    <display value="SE-UHPLC Main Peak - 25"/>
  </concept>
  <concept>
    <code value="SIZE"/>
    <display value="Particle Size"/>
  </concept>
  <concept>
    <code value="SOL"/>
    <display value="Residual solvents"/>
  </concept>
  <concept>
    <code value="SOLV"/>
    <display value="Solvent"/>
  </concept>
  <concept>
    <code value="SSE"/>
    <display value="Statistically significant effects"/>
  </concept>
  <concept>
    <code value="TEMP"/>
    <display value="Temperature"/>
  </concept>
  <concept>
    <code value="UCL"/>
    <display value="Upper one-sided 95% confidence limit of Max Difference"/>
  </concept>
  <concept>
    <code value="uniformity-dosage"/>
    <display value="uniformity of dosage units (by weight)"/>
  </concept>
  <concept>
    <code value="WWWH"/>
    <display value="Water Content Homogeneity"/>
  </concept>
  <concept>
    <code value="SAMP"/>
    <display value="Number of Samples"/>
  </concept>
  <concept>
    <code value="DGP"/>
    <display value="Degradation Products"/>
  </concept>
  <concept>
    <code value="DGP-s"/>
    <display value="Drug Substance Related Organic impurities"/>
  </concept>
  <concept>
    <code value="IMP"/>
    <display value="Impurity"/>
  </concept>
  <concept>
    <code value="Impurities"/>
    <display value="Impurities"/>
  </concept>
  <concept>
    <code value="WWW"/>
    <display value="Water Content"/>
  </concept>
  <concept>
    <code value="Microbiological Quality"/>
    <display value="Microbiological Quality"/>
  </concept>
  <concept>
    <code value="ASSAY"/>
    <display value="Assay"/>
  </concept>
  <concept>
    <code value="CEX-HPLCAcidicPeak"/>
    <display value="CEX-HPLC Acidic Peak"/>
  </concept>
  <concept>
    <code value="CEX-HPLCMainPeak"/>
    <display value="CEX-HPLC Main Peak"/>
  </concept>
  <concept>
    <code value="PART"/>
    <display value="Particle size distribution"/>
  </concept>
  <concept>
    <code value="ASSH"/>
    <display value="Assay Content Homogeneity"/>
  </concept>
  <concept>
    <code value="DESC"/>
    <display value="Description"/>
  </concept>
  <concept>
    <code value="Dissolution"/>
    <display value="Dissolution"/>
  </concept>
  <concept>
    <code value="Dissolution Quantity"/>
    <display value="Dissolution Quantity"/>
  </concept>
  <concept>
    <code value="ELE"/>
    <display value="Elemental impurities"/>
  </concept>
  <concept>
    <code value="enantiomeric-purity"/>
    <display value="Enantiomeric purity"/>
  </concept>
  <concept>
    <code value="IDT"/>
    <display value="Identification"/>
  </concept>
  <concept>
    <code value="MUT"/>
    <display value="Mutagenic impurities"/>
  </concept>
  <concept>
    <code value="NMR"/>
    <display value="NMR"/>
  </concept>
  <concept>
    <code value="NMR-C"/>
    <display value="NMR-C"/>
  </concept>
  <concept>
    <code value="NMR-H"/>
    <display value="NMR-H"/>
  </concept>
  <concept>
    <code value="CEX-HPLCAcidicPeak-15"/>
    <display value="CEX-HPLC Acidic Peak - 15"/>
  </concept>
  <concept>
    <code value="CEX-HPLCAcidicPeak-25"/>
    <display value="CEX-HPLC Acidic Peak - 25"/>
  </concept>
  <concept>
    <code value="CEX-HPLCMainPeak-15"/>
    <display value="CEX-HPLC Main Peak - 15"/>
  </concept>
  <concept>
    <code value="CEX-HPLCMainPeak-25"/>
    <display value="CEX-HPLC Main Peak - 25"/>
  </concept>
  <concept>
    <code value="Homogeneity"/>
    <display value="Homogeneity demonstrated"/>
  </concept>
  <concept>
    <code value="LCL"/>
    <display value="Lower one-sided 95% confidence limit of Max Difference"/>
  </concept>
  <concept>
    <code value="LOC"/>
    <display value="Number of Locations"/>
  </concept>
  <concept>
    <code value="PARTS"/>
    <display value="Particle size"/>
  </concept>
  <concept>
    <code value="POS"/>
    <display value="Structure Position"/>
  </concept>
  <concept>
    <code value="particle-size-distribution"/>
    <display value="Particle size distribution"/>
  </concept>
  <concept>
    <code value="Lyophilization Water Homogeneity"/>
    <display value="Lyophilization Water Homogeneity"/>
  </concept>
  <concept>
    <code value="Lyophilization Assay Homogeneity"/>
    <display value="Lyophilization Assay Homogeneity"/>
  </concept>
  <concept>
    <code value="Particle Size RSD"/>
    <display value="Particle Size RSD"/>
  </concept>
  <concept>
    <code value="Obscuration"/>
    <display value="Obscuration"/>
  </concept>
  <concept>
    <code value="Refractive index"/>
    <display value="Refractive index"/>
  </concept>
  <concept>
    <code value="ElementalAnalysisCarbon"/>
    <display value="Elemental Analysis Carbon (%)"/>
  </concept>
  <concept>
    <code value="IonAnalysisCarbonMass"/>
    <display value="Ion Analysis Carbon - Mass"/>
  </concept>
  <concept>
    <code value="IonAnalysisCarbonMassAccuracy"/>
    <display value="Ion Analysis Carbon - Mass Accuracy"/>
  </concept>
  <concept>
    <code value="IonAnalysisCarbon"/>
    <display value="Ion Analysis Carbon (%)"/>
  </concept>
  <concept>
    <code value="ElementalAnalysisHydrogen"/>
    <display value="Elemental Analysis Hydrogen (%)"/>
  </concept>
  <concept>
    <code value="IonAnalysisHydrogenMass"/>
    <display value="Ion Analysis Hydrogen - Mass"/>
  </concept>
  <concept>
    <code value="IonAnalysisHydrogenMassAccuracy"/>
    <display value="Ion Analysis Hydrogen - Mass Accuracy"/>
  </concept>
  <concept>
    <code value="IonAnalysisHydrogen"/>
    <display value="Ion Analysis Hydrogen (%)"/>
  </concept>
  <concept>
    <code value="ElementalAnalysisNitrogen"/>
    <display value="Elemental Analysis Nitrogen (%)"/>
  </concept>
  <concept>
    <code value="IonAnalysisNitrogen"/>
    <display value="Ion Analysis Nitrogen (%)"/>
  </concept>
  <concept>
    <code value="IonAnalysisNitrogenMass"/>
    <display value="Ion Analysis Nitrogen - Mass"/>
  </concept>
  <concept>
    <code value="IonAnalysisNitrogenMassAccuracy"/>
    <display value="Ion Analysis Nitrogen - Mass Accuracy"/>
  </concept>
  <concept>
    <code value="ElementalAnalysisFlourine"/>
    <display value="Elemental Analysis Flourine (%)"/>
  </concept>
  <concept>
    <code value="IonAnalysisFlourine"/>
    <display value="Ion Analysis Flourine (%)"/>
  </concept>
  <concept>
    <code value="IonAnalysisFlourineMass"/>
    <display value="Ion Analysis Flourine - Mass"/>
  </concept>
  <concept>
    <code value="IonAnalysisFlourineMassAccuracy"/>
    <display value="Ion Analysis Flourine - Mass Accuracy"/>
  </concept>
  <concept>
    <code value="Chemical Structure"/>
    <display value="Chemical Structure"/>
  </concept>
  <concept>
    <code value="Diffractogram"/>
    <display value="Diffractogram"/>
  </concept>
  <concept>
    <code value="MolecularStructure"/>
    <display value="Molecular Structure"/>
  </concept>
  <concept>
    <code value="Absorption"/>
    <display value="Absorption"/>
  </concept>
  <concept>
    <code value="X-Ray Powder Diffractogram"/>
    <display value="X-Ray Powder Diffractogram"/>
  </concept>
  <concept>
    <code value="pH (post-dilution bulk solution)"/>
    <display value="pH (post-dilution bulk solution)"/>
  </concept>
  <concept>
    <code value="Appearance (Product Container, visual)"/>
    <display value="Appearance (Product Container, visual)"/>
  </concept>
  <concept>
    <code value="Appearance (Lyophilized, Visual)"/>
    <display value="Appearance (Lyophilized, Visual)"/>
  </concept>
  <concept>
    <code value="Appearance (Reconstituted, Visual)"/>
    <display value="Appearance (Reconstituted, Visual)"/>
  </concept>
  <concept>
    <code value="Appearance"/>
    <display value="Appearance"/>
  </concept>
  <concept>
    <code value="pH (reconstituted)"/>
    <display value="pH (reconstituted)"/>
  </concept>
  <concept>
    <code value="TAMC"/>
    <display value="TAMC"/>
  </concept>
  <concept>
    <code value="Fill Weight Average"/>
    <display value="Fill Weight Average"/>
  </concept>
  <concept>
    <code value="Fill Weight Target (g)"/>
    <display value="Fill Weight Target (g)"/>
  </concept>
  <concept>
    <code value="Actual Avg. Weight from Target"/>
    <display value="Actual Avg. Weight from Target"/>
  </concept>
  <concept>
    <code value="Hold Time (filtration To filling)"/>
    <display value="Hold Time (filtration To filling)"/>
  </concept>
  <concept>
    <code value="Hold Time (start filling to end filling)"/>
    <display value="Hold Time (start filling to end filling)"/>
  </concept>
  <concept>
    <code value="Filter Integrity Test"/>
    <display value="Filter Integrity Test"/>
  </concept>
  <concept>
    <code value="Lyophilizer Number"/>
    <display value="Lyophilizer Number"/>
  </concept>
  <concept>
    <code value="pH (adjustment of pre-clarification bulk solution)"/>
    <display value="pH (adjustment of pre-clarification bulk solution)"/>
  </concept>
  <concept>
    <code value="Assay (pre-clarification filtration) (mg/mL)"/>
    <display value="Assay (pre-clarification filtration) (mg/mL)"/>
  </concept>
  <concept>
    <code value="Assay (Post dilution bulk solution) (mg/mL)"/>
    <display value="Assay (Post dilution bulk solution) (mg/mL)"/>
  </concept>
  <concept>
    <code value="Test Date"/>
    <display value="Test Date"/>
  </concept>
  <concept>
    <code value="Identification (NMR)"/>
    <display value="Identification (NMR)"/>
  </concept>
  <concept>
    <code value="Identification (FT-IR)"/>
    <display value="Identification (FT-IR)"/>
  </concept>
  <concept>
    <code value="VisualInspection"/>
    <display value="VisualInspection"/>
  </concept>
  <concept>
    <code value="InfraredSpectroscopy"/>
    <display value="InfraredSpectroscopy"/>
  </concept>
  <concept>
    <code value="SupplierCertificateofAnalysis"/>
    <display value="SupplierCertificateofAnalysis"/>
  </concept>
  <concept>
    <code value="Elemental"/>
    <display value="Elemental"/>
  </concept>
  <concept>
    <code value="Uniformity of Dosage Units, Weight Variation"/>
    <display value="Uniformity of Dosage Units, Weight Variation"/>
  </concept>
  <concept>
    <code
          value="Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"/>
    <display
             value="Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)"/>
  </concept>
  <concept>
    <code value="Yield (%)"/>
    <display value="Yield (%)"/>
  </concept>
  <concept>
    <code value="ResidualWaterContent"/>
    <display value="Residual Water Content (w/w%)"/>
  </concept>
  <concept>
    <code value="Reaction conversion: Residual Starting Material 1 by HPLC"/>
    <display
             value="Reaction conversion: Residual Starting Material 1 by HPLC"/>
  </concept>
  <concept>
    <code value="Bacterial Endotoxins (EU/mL)"/>
    <display value="Bacterial Endotoxins (EU/mL)"/>
  </concept>
  <concept>
    <code value="Bioburden - Beginning"/>
    <display value="Bioburden - Beginning"/>
  </concept>
  <concept>
    <code value="Bioburden - End"/>
    <display value="Bioburden - End"/>
  </concept>
  <concept>
    <code value="Bioburden (CFU/ 100 mL)"/>
    <display value="Bioburden (CFU/ 100 mL)"/>
  </concept>
  <concept>
    <code value="Buffer vessel mixing speed (rpm)"/>
    <display value="Buffer vessel mixing speed (rpm)"/>
  </concept>
  <concept>
    <code value="Buffer vessel mixing time (min)"/>
    <display value="Buffer vessel mixing time (min)"/>
  </concept>
  <concept>
    <code value="CONC"/>
    <display value="Conclusion"/>
  </concept>
  <concept>
    <code value="Conductivity (μS/cm)"/>
    <display value="Conductivity (μS/cm)"/>
  </concept>
  <concept>
    <code value="Fill Weight"/>
    <display value="Fill Weight"/>
  </concept>
  <concept>
    <code value="Fill Weight - Maximum"/>
    <display value="Fill Weight - Maximum"/>
  </concept>
  <concept>
    <code value="Fill Weight - Mean"/>
    <display value="Fill Weight - Mean"/>
  </concept>
  <concept>
    <code value="Fill Weight - Minimum"/>
    <display value="Fill Weight - Minimum"/>
  </concept>
  <concept>
    <code value="FiltrationPressure (psig)"/>
    <display value="FiltrationPressure (psig)"/>
  </concept>
  <concept>
    <code value="Formulation vessel mixing speed (rpm)"/>
    <display value="Formulation vessel mixing speed (rpm)"/>
  </concept>
  <concept>
    <code value="Formulation vessel mixing time (min)"/>
    <display value="Formulation vessel mixing time (min)"/>
  </concept>
  <concept>
    <code value="Growth Promotion - Beginning"/>
    <display value="Growth Promotion - Beginning"/>
  </concept>
  <concept>
    <code value="Growth Promotion - End"/>
    <display value="Growth Promotion - End"/>
  </concept>
  <concept>
    <code value="GrowthPromotion"/>
    <display value="Growth Promotion"/>
  </concept>
  <concept>
    <code value="Hold Time"/>
    <display value="Hold Time"/>
  </concept>
  <concept>
    <code value="LyophilizationHomogeneneity"/>
    <display value="Lyophilization Homogeneneity"/>
  </concept>
  <concept>
    <code value="Media Challenge Hold Times"/>
    <display value="Media Challenge Hold Times"/>
  </concept>
  <concept>
    <code value="MediaChallengeRun"/>
    <display value="Media Challenge Run"/>
  </concept>
  <concept>
    <code value="Osmolality"/>
    <display value="Osmolality"/>
  </concept>
  <concept>
    <code value="OVERALLSAMP"/>
    <display value="Number of Samples"/>
  </concept>
  <concept>
    <code value="particle-size"/>
    <display value="Particle Size"/>
  </concept>
  <concept>
    <code value="pH"/>
    <display value="pH"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 (% w/v)"/>
    <display value="Polysorbate 80 (% w/v)"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration - Beginning - Max"/>
    <display value="Polysorbate 80 concentration - Beginning - Max"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration - Beginning - Min"/>
    <display value="Polysorbate 80 concentration - Beginning - Min"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration - End - Max"/>
    <display value="Polysorbate 80 concentration - End - Max"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration - End - Min"/>
    <display value="Polysorbate 80 concentration - End - Min"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration - Middle - Max"/>
    <display value="Polysorbate 80 concentration - Middle - Max"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration - Middle - Min"/>
    <display value="Polysorbate 80 concentration - Middle - Min"/>
  </concept>
  <concept>
    <code value="Polysorbate 80 concentration (% w/v)"/>
    <display value="Polysorbate 80 concentration (% w/v)"/>
  </concept>
  <concept>
    <code value="Post-filtration Filter Integrity (psig)"/>
    <display value="Post-filtration Filter Integrity (psig)"/>
  </concept>
  <concept>
    <code value="Pre-filtration Bioburden (CFU/ 100 mL)"/>
    <display value="Pre-filtration Bioburden (CFU/ 100 mL)"/>
  </concept>
  <concept>
    <code value="Protein Concentration (mg/mL)"/>
    <display value="Protein Concentration (mg/mL)"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - End - Higher"/>
    <display value="Protein Concentration - Beginning - End - Higher"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - End - Lower"/>
    <display value="Protein Concentration - Beginning - End - Lower"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - End - Mean"/>
    <display value="Protein Concentration - Beginning - End - Mean"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - Max"/>
    <display value="Protein Concentration - Beginning - Max"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - Middle - Higher"/>
    <display value="Protein Concentration - Beginning - Middle - Higher"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - Middle - Lower"/>
    <display value="Protein Concentration - Beginning - Middle - Lower"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - Middle - Mean"/>
    <display value="Protein Concentration - Beginning - Middle - Mean"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Beginning - Min"/>
    <display value="Protein Concentration - Beginning - Min"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Conclusion"/>
    <display value="Protein Concentration - Conclusion"/>
  </concept>
  <concept>
    <code value="Protein Concentration - End - Max"/>
    <display value="Protein Concentration - End - Max"/>
  </concept>
  <concept>
    <code value="Protein Concentration - End - Min"/>
    <display value="Protein Concentration - End - Min"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Middle - End - Higher"/>
    <display value="Protein Concentration - Middle - End - Higher"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Middle - End - Lower"/>
    <display value="Protein Concentration - Middle - End - Lower"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Middle - End - Mean"/>
    <display value="Protein Concentration - Middle - End - Mean"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Middle - Max"/>
    <display value="Protein Concentration - Middle - Max"/>
  </concept>
  <concept>
    <code value="Protein Concentration - Middle - Min"/>
    <display value="Protein Concentration - Middle - Min"/>
  </concept>
  <concept>
    <code value="Protein Concentration Statistics"/>
    <display value="Protein Concentration Statistics"/>
  </concept>
  <concept>
    <code value="Residual Moisture - Max"/>
    <display value="Residual Moisture - Max"/>
  </concept>
  <concept>
    <code value="Residual Moisture - Min"/>
    <display value="Residual Moisture - Min"/>
  </concept>
  <concept>
    <code value="Residual Moisture"/>
    <display value="Residual Moisture"/>
  </concept>
  <concept>
    <code value="SE-UHPLC Main Peak - Beginning"/>
    <display value="SE-UHPLC Main Peak - Beginning"/>
  </concept>
  <concept>
    <code value="SE-UHPLC HMW - Conclusion"/>
    <display value="SE-UHPLC HMW - Conclusion"/>
  </concept>
  <concept>
    <code value="SE-UHPLC Main Peak - Conclusion"/>
    <display value="SE-UHPLC Main Peak - Conclusion"/>
  </concept>
  <concept>
    <code value="SE-UHPLC Main Peak - End"/>
    <display value="SE-UHPLC Main Peak - End"/>
  </concept>
  <concept>
    <code value="SE-UHPLCHMW - Beginning"/>
    <display value="SE-UHPLC HMW - Beginning"/>
  </concept>
  <concept>
    <code value="SE-UHPLCHMW - End"/>
    <display value="SE-UHPLC HMW - End"/>
  </concept>
  <concept>
    <code value="SE-UHPLCHMWPeak - Conclusion"/>
    <display value="SE-UHPLC HMW Peak - Conclusion"/>
  </concept>
  <concept>
    <code value="SE-UHPLCHMW"/>
    <display value="SE-UHPLC HMW"/>
  </concept>
  <concept>
    <code value="SE-UHPLCMainPeak - Conclusion"/>
    <display value="SE-UHPLC Main Peak - Conclusion"/>
  </concept>
  <concept>
    <code value="SE-UHPLCMainPeak"/>
    <display value="SE-UHPLC Main Peak"/>
  </concept>
  <concept>
    <code value="test-success"/>
    <display value="Test Success"/>
  </concept>
  <concept>
    <code value="Thaw Time"/>
    <display value="Thaw Time"/>
  </concept>
  <concept>
    <code value="Thawing Temp"/>
    <display value="Thawing Temp"/>
  </concept>
  <concept>
    <code value="WaterContent"/>
    <display value="Water content"/>
  </concept>
  <concept>
    <code value="AssignedPurity"/>
    <display value="Assigned Purity"/>
  </concept>
  <concept>
    <code value="1d2344"/>
    <display value="Tape"/>
  </concept>
  <concept>
    <code value="200000003208"/>
    <display value="Plastic"/>
  </concept>
  <concept>
    <code value="112344ss"/>
    <display value="PVC"/>
  </concept>
</CodeSystem>