Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-18 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="cs-local-codes-drug-pq"/>
<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</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-ionic-strength"> </a></td><td>Ionic Strength</td></tr><tr><td style="white-space:nowrap">physicochemical<a name="cs-local-codes-drug-pq-physicochemical"> </a></td><td>Physicochemical properties</td></tr><tr><td style="white-space:nowrap">SE-UHPLCHMW-15<a name="cs-local-codes-drug-pq-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-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-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-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-SIZE"> </a></td><td>Particle Size</td></tr><tr><td style="white-space:nowrap">SOL<a name="cs-local-codes-drug-pq-SOL"> </a></td><td>Residual solvents</td></tr><tr><td style="white-space:nowrap">SOLV<a name="cs-local-codes-drug-pq-SOLV"> </a></td><td>Solvent</td></tr><tr><td style="white-space:nowrap">SSE<a name="cs-local-codes-drug-pq-SSE"> </a></td><td>Statistically significant effects</td></tr><tr><td style="white-space:nowrap">TEMP<a name="cs-local-codes-drug-pq-TEMP"> </a></td><td>Temperature</td></tr><tr><td style="white-space:nowrap">UCL<a name="cs-local-codes-drug-pq-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-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-WWWH"> </a></td><td>Water Content Homogeneity</td></tr><tr><td style="white-space:nowrap">SAMP<a name="cs-local-codes-drug-pq-SAMP"> </a></td><td>Number of Samples</td></tr><tr><td style="white-space:nowrap">DGP<a name="cs-local-codes-drug-pq-DGP"> </a></td><td>Degradation Products</td></tr><tr><td style="white-space:nowrap">DGP-s<a name="cs-local-codes-drug-pq-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-IMP"> </a></td><td>Impurity</td></tr><tr><td style="white-space:nowrap">Impurities<a name="cs-local-codes-drug-pq-Impurities"> </a></td><td>Impurities</td></tr><tr><td style="white-space:nowrap">WWW<a name="cs-local-codes-drug-pq-WWW"> </a></td><td>Water Content</td></tr><tr><td style="white-space:nowrap">Microbiological Quality<a name="cs-local-codes-drug-pq-MicrobiologicalQuality"> </a></td><td>Microbiological Quality</td></tr><tr><td style="white-space:nowrap">ASSAY<a name="cs-local-codes-drug-pq-ASSAY"> </a></td><td>Assay</td></tr><tr><td style="white-space:nowrap">CEX-HPLCAcidicPeak<a name="cs-local-codes-drug-pq-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-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-PART"> </a></td><td>Particle size distribution</td></tr><tr><td style="white-space:nowrap">ASSH<a name="cs-local-codes-drug-pq-ASSH"> </a></td><td>Assay Content Homogeneity</td></tr><tr><td style="white-space:nowrap">DESC<a name="cs-local-codes-drug-pq-DESC"> </a></td><td>Description</td></tr><tr><td style="white-space:nowrap">Dissolution<a name="cs-local-codes-drug-pq-Dissolution"> </a></td><td>Dissolution</td></tr><tr><td style="white-space:nowrap">Dissolution Quantity<a name="cs-local-codes-drug-pq-DissolutionQuantity"> </a></td><td>Dissolution Quantity</td></tr><tr><td style="white-space:nowrap">ELE<a name="cs-local-codes-drug-pq-ELE"> </a></td><td>Elemental impurities</td></tr><tr><td style="white-space:nowrap">enantiomeric-purity<a name="cs-local-codes-drug-pq-enantiomeric-purity"> </a></td><td>Enantiomeric purity</td></tr><tr><td style="white-space:nowrap">IDT<a name="cs-local-codes-drug-pq-IDT"> </a></td><td>Identification</td></tr><tr><td style="white-space:nowrap">MUT<a name="cs-local-codes-drug-pq-MUT"> </a></td><td>Mutagenic impurities</td></tr><tr><td style="white-space:nowrap">NMR<a name="cs-local-codes-drug-pq-NMR"> </a></td><td>NMR</td></tr><tr><td style="white-space:nowrap">NMR-C<a name="cs-local-codes-drug-pq-NMR-C"> </a></td><td>NMR-C</td></tr><tr><td style="white-space:nowrap">NMR-H<a name="cs-local-codes-drug-pq-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-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-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-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-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-Homogeneity"> </a></td><td>Homogeneity demonstrated</td></tr><tr><td style="white-space:nowrap">LCL<a name="cs-local-codes-drug-pq-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-LOC"> </a></td><td>Number of Locations</td></tr><tr><td style="white-space:nowrap">PARTS<a name="cs-local-codes-drug-pq-PARTS"> </a></td><td>Particle size</td></tr><tr><td style="white-space:nowrap">POS<a name="cs-local-codes-drug-pq-POS"> </a></td><td>Structure Position</td></tr><tr><td style="white-space:nowrap">particle-size-distribution<a name="cs-local-codes-drug-pq-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-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-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-ParticleSizeRSD"> </a></td><td>Particle Size RSD</td></tr><tr><td style="white-space:nowrap">Obscuration<a name="cs-local-codes-drug-pq-Obscuration"> </a></td><td>Obscuration</td></tr><tr><td style="white-space:nowrap">Refractive index<a name="cs-local-codes-drug-pq-Refractiveindex"> </a></td><td>Refractive index</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisCarbon<a name="cs-local-codes-drug-pq-ElementalAnalysisCarbon"> </a></td><td>Elemental Analysis Carbon (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisCarbonMass<a name="cs-local-codes-drug-pq-IonAnalysisCarbonMass"> </a></td><td>Ion Analysis Carbon - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisCarbonMassAccuracy<a name="cs-local-codes-drug-pq-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-IonAnalysisCarbon"> </a></td><td>Ion Analysis Carbon (%)</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisHydrogen<a name="cs-local-codes-drug-pq-ElementalAnalysisHydrogen"> </a></td><td>Elemental Analysis Hydrogen (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisHydrogenMass<a name="cs-local-codes-drug-pq-IonAnalysisHydrogenMass"> </a></td><td>Ion Analysis Hydrogen - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisHydrogenMassAccuracy<a name="cs-local-codes-drug-pq-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-IonAnalysisHydrogen"> </a></td><td>Ion Analysis Hydrogen (%)</td></tr><tr><td style="white-space:nowrap">ElementalAnalysisNitrogen<a name="cs-local-codes-drug-pq-ElementalAnalysisNitrogen"> </a></td><td>Elemental Analysis Nitrogen (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisNitrogen<a name="cs-local-codes-drug-pq-IonAnalysisNitrogen"> </a></td><td>Ion Analysis Nitrogen (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisNitrogenMass<a name="cs-local-codes-drug-pq-IonAnalysisNitrogenMass"> </a></td><td>Ion Analysis Nitrogen - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisNitrogenMassAccuracy<a name="cs-local-codes-drug-pq-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-ElementalAnalysisFlourine"> </a></td><td>Elemental Analysis Flourine (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisFlourine<a name="cs-local-codes-drug-pq-IonAnalysisFlourine"> </a></td><td>Ion Analysis Flourine (%)</td></tr><tr><td style="white-space:nowrap">IonAnalysisFlourineMass<a name="cs-local-codes-drug-pq-IonAnalysisFlourineMass"> </a></td><td>Ion Analysis Flourine - Mass</td></tr><tr><td style="white-space:nowrap">IonAnalysisFlourineMassAccuracy<a name="cs-local-codes-drug-pq-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-ChemicalStructure"> </a></td><td>Chemical Structure</td></tr><tr><td style="white-space:nowrap">Diffractogram<a name="cs-local-codes-drug-pq-Diffractogram"> </a></td><td>Diffractogram</td></tr><tr><td style="white-space:nowrap">MolecularStructure<a name="cs-local-codes-drug-pq-MolecularStructure"> </a></td><td>Molecular Structure</td></tr><tr><td style="white-space:nowrap">Absorption<a name="cs-local-codes-drug-pq-Absorption"> </a></td><td>Absorption</td></tr><tr><td style="white-space:nowrap">X-Ray Powder Diffractogram<a name="cs-local-codes-drug-pq-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-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-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-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-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-Appearance"> </a></td><td>Appearance</td></tr><tr><td style="white-space:nowrap">pH (reconstituted)<a name="cs-local-codes-drug-pq-pH.40reconstituted.41"> </a></td><td>pH (reconstituted)</td></tr><tr><td style="white-space:nowrap">TAMC<a name="cs-local-codes-drug-pq-TAMC"> </a></td><td>TAMC</td></tr><tr><td style="white-space:nowrap">Fill Weight Average<a name="cs-local-codes-drug-pq-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-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-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-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-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-FilterIntegrityTest"> </a></td><td>Filter Integrity Test</td></tr><tr><td style="white-space:nowrap">Lyophilizer Number<a name="cs-local-codes-drug-pq-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-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-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-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-TestDate"> </a></td><td>Test Date</td></tr><tr><td style="white-space:nowrap">Identification (NMR)<a name="cs-local-codes-drug-pq-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-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-VisualInspection"> </a></td><td>VisualInspection</td></tr><tr><td style="white-space:nowrap">InfraredSpectroscopy<a name="cs-local-codes-drug-pq-InfraredSpectroscopy"> </a></td><td>InfraredSpectroscopy</td></tr><tr><td style="white-space:nowrap">SupplierCertificateofAnalysis<a name="cs-local-codes-drug-pq-SupplierCertificateofAnalysis"> </a></td><td>SupplierCertificateofAnalysis</td></tr><tr><td style="white-space:nowrap">Elemental<a name="cs-local-codes-drug-pq-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-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-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-Yield.40.37.41"> </a></td><td>Yield (%)</td></tr><tr><td style="white-space:nowrap">ResidualWaterContent<a name="cs-local-codes-drug-pq-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-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-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-Bioburden-Beginning"> </a></td><td>Bioburden - Beginning</td></tr><tr><td style="white-space:nowrap">Bioburden - End<a name="cs-local-codes-drug-pq-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-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-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-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-CONC"> </a></td><td>Conclusion</td></tr><tr><td style="white-space:nowrap">Conductivity (μS/cm)<a name="cs-local-codes-drug-pq-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-FillWeight"> </a></td><td>Fill Weight</td></tr><tr><td style="white-space:nowrap">Fill Weight - Maximum<a name="cs-local-codes-drug-pq-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-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-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-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-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-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-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-GrowthPromotion-End"> </a></td><td>Growth Promotion - End</td></tr><tr><td style="white-space:nowrap">GrowthPromotion<a name="cs-local-codes-drug-pq-GrowthPromotion"> </a></td><td>Growth Promotion</td></tr><tr><td style="white-space:nowrap">Hold Time<a name="cs-local-codes-drug-pq-HoldTime"> </a></td><td>Hold Time</td></tr><tr><td style="white-space:nowrap">LyophilizationHomogeneneity<a name="cs-local-codes-drug-pq-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-MediaChallengeHoldTimes"> </a></td><td>Media Challenge Hold Times</td></tr><tr><td style="white-space:nowrap">MediaChallengeRun<a name="cs-local-codes-drug-pq-MediaChallengeRun"> </a></td><td>Media Challenge Run</td></tr><tr><td style="white-space:nowrap">Osmolality<a name="cs-local-codes-drug-pq-Osmolality"> </a></td><td>Osmolality</td></tr><tr><td style="white-space:nowrap">OVERALLSAMP<a name="cs-local-codes-drug-pq-OVERALLSAMP"> </a></td><td>Number of Samples</td></tr><tr><td style="white-space:nowrap">particle-size<a name="cs-local-codes-drug-pq-particle-size"> </a></td><td>Particle Size</td></tr><tr><td style="white-space:nowrap">pH<a name="cs-local-codes-drug-pq-pH"> </a></td><td>pH</td></tr><tr><td style="white-space:nowrap">Polysorbate 80 (% w/v)<a name="cs-local-codes-drug-pq-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-test-success"> </a></td><td>Test Success</td></tr><tr><td style="white-space:nowrap">Thaw Time<a name="cs-local-codes-drug-pq-ThawTime"> </a></td><td>Thaw Time</td></tr><tr><td style="white-space:nowrap">Thawing Temp<a name="cs-local-codes-drug-pq-ThawingTemp"> </a></td><td>Thawing Temp</td></tr><tr><td style="white-space:nowrap">WaterContent<a name="cs-local-codes-drug-pq-WaterContent"> </a></td><td>Water content</td></tr><tr><td style="white-space:nowrap">AssignedPurity<a name="cs-local-codes-drug-pq-AssignedPurity"> </a></td><td>Assigned Purity</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"/>
<version value="1.0.0-ballot"/>
<name value="CsLocalCodesDrugPQ"/>
<title value="CodeSystem - Example Local Codes - Drug"/>
<status value="active"/>
<experimental value="false"/>
<date value="2023-12-18T16:00:45+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 code system contains temporary example codes for use in PQ."/>
<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>
</CodeSystem>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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