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 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "cs-local-codes-drug-pq"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "brr" ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.0.0-ballot"] ; # fhir:name [ fhir:v "CsLocalCodesDrugPQ"] ; # fhir:title [ fhir:v "CodeSystem - Example Local Codes - Drug"] ; # fhir:status [ fhir:v "active"] ; # fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # fhir:date [ fhir:v "2023-12-18T16:00:45+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International - Biomedical Research and Regulation" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] ) ] ) ; # fhir:description [ fhir:v "This code system contains temporary example codes for use in PQ."] ; # fhir:jurisdiction ( [ ( fhir:coding [ fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ; fhir:code [ fhir:v "001" ] ; fhir:display [ fhir:v "World" ] ] ) ; fhir:text [ fhir:v "World" ] ] ) ; # fhir:caseSensitive [ fhir:v "true"^^xsd:boolean] ; # fhir:content [ fhir:v "complete"] ; # fhir:concept ( [ fhir:code [ fhir:v "ionic-strength" ] ; fhir:display [ fhir:v "Ionic Strength" ] ] [ fhir:code [ fhir:v "physicochemical" ] ; fhir:display [ fhir:v "Physicochemical properties" ] ] [ fhir:code [ fhir:v "SE-UHPLCHMW-15" ] ; fhir:display [ fhir:v "SE-UHPLC HMW - 15" ] ] [ fhir:code [ fhir:v "SE-UHPLCHMW-25" ] ; fhir:display [ fhir:v "SE-UHPLC HMW - 25" ] ] [ fhir:code [ fhir:v "SE-UHPLCMainPeak-15" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak - 15" ] ] [ fhir:code [ fhir:v "SE-UHPLCMainPeak-25" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak - 25" ] ] [ fhir:code [ fhir:v "SIZE" ] ; fhir:display [ fhir:v "Particle Size" ] ] [ fhir:code [ fhir:v "SOL" ] ; fhir:display [ fhir:v "Residual solvents" ] ] [ fhir:code [ fhir:v "SOLV" ] ; fhir:display [ fhir:v "Solvent" ] ] [ fhir:code [ fhir:v "SSE" ] ; fhir:display [ fhir:v "Statistically significant effects" ] ] [ fhir:code [ fhir:v "TEMP" ] ; fhir:display [ fhir:v "Temperature" ] ] [ fhir:code [ fhir:v "UCL" ] ; fhir:display [ fhir:v "Upper one-sided 95% confidence limit of Max Difference" ] ] [ fhir:code [ fhir:v "uniformity-dosage" ] ; fhir:display [ fhir:v "uniformity of dosage units (by weight)" ] ] [ fhir:code [ fhir:v "WWWH" ] ; fhir:display [ fhir:v "Water Content Homogeneity" ] ] [ fhir:code [ fhir:v "SAMP" ] ; fhir:display [ fhir:v "Number of Samples" ] ] [ fhir:code [ fhir:v "DGP" ] ; fhir:display [ fhir:v "Degradation Products" ] ] [ fhir:code [ fhir:v "DGP-s" ] ; fhir:display [ fhir:v "Drug Substance Related Organic impurities" ] ] [ fhir:code [ fhir:v "IMP" ] ; fhir:display [ fhir:v "Impurity" ] ] [ fhir:code [ fhir:v "Impurities" ] ; fhir:display [ fhir:v "Impurities" ] ] [ fhir:code [ fhir:v "WWW" ] ; fhir:display [ fhir:v "Water Content" ] ] [ fhir:code [ fhir:v "Microbiological Quality" ] ; fhir:display [ fhir:v "Microbiological Quality" ] ] [ fhir:code [ fhir:v "ASSAY" ] ; fhir:display [ fhir:v "Assay" ] ] [ fhir:code [ fhir:v "CEX-HPLCAcidicPeak" ] ; fhir:display [ fhir:v "CEX-HPLC Acidic Peak" ] ] [ fhir:code [ fhir:v "CEX-HPLCMainPeak" ] ; fhir:display [ fhir:v "CEX-HPLC Main Peak" ] ] [ fhir:code [ fhir:v "PART" ] ; fhir:display [ fhir:v "Particle size distribution" ] ] [ fhir:code [ fhir:v "ASSH" ] ; fhir:display [ fhir:v "Assay Content Homogeneity" ] ] [ fhir:code [ fhir:v "DESC" ] ; fhir:display [ fhir:v "Description" ] ] [ fhir:code [ fhir:v "Dissolution" ] ; fhir:display [ fhir:v "Dissolution" ] ] [ fhir:code [ fhir:v "Dissolution Quantity" ] ; fhir:display [ fhir:v "Dissolution Quantity" ] ] [ fhir:code [ fhir:v "ELE" ] ; fhir:display [ fhir:v "Elemental impurities" ] ] [ fhir:code [ fhir:v "enantiomeric-purity" ] ; fhir:display [ fhir:v "Enantiomeric purity" ] ] [ fhir:code [ fhir:v "IDT" ] ; fhir:display [ fhir:v "Identification" ] ] [ fhir:code [ fhir:v "MUT" ] ; fhir:display [ fhir:v "Mutagenic impurities" ] ] [ fhir:code [ fhir:v "NMR" ] ; fhir:display [ fhir:v "NMR" ] ] [ fhir:code [ fhir:v "NMR-C" ] ; fhir:display [ fhir:v "NMR-C" ] ] [ fhir:code [ fhir:v "NMR-H" ] ; fhir:display [ fhir:v "NMR-H" ] ] [ fhir:code [ fhir:v "CEX-HPLCAcidicPeak-15" ] ; fhir:display [ fhir:v "CEX-HPLC Acidic Peak - 15" ] ] [ fhir:code [ fhir:v "CEX-HPLCAcidicPeak-25" ] ; fhir:display [ fhir:v "CEX-HPLC Acidic Peak - 25" ] ] [ fhir:code [ fhir:v "CEX-HPLCMainPeak-15" ] ; fhir:display [ fhir:v "CEX-HPLC Main Peak - 15" ] ] [ fhir:code [ fhir:v "CEX-HPLCMainPeak-25" ] ; fhir:display [ fhir:v "CEX-HPLC Main Peak - 25" ] ] [ fhir:code [ fhir:v "Homogeneity" ] ; fhir:display [ fhir:v "Homogeneity demonstrated" ] ] [ fhir:code [ fhir:v "LCL" ] ; fhir:display [ fhir:v "Lower one-sided 95% confidence limit of Max Difference" ] ] [ fhir:code [ fhir:v "LOC" ] ; fhir:display [ fhir:v "Number of Locations" ] ] [ fhir:code [ fhir:v "PARTS" ] ; fhir:display [ fhir:v "Particle size" ] ] [ fhir:code [ fhir:v "POS" ] ; fhir:display [ fhir:v "Structure Position" ] ] [ fhir:code [ fhir:v "particle-size-distribution" ] ; fhir:display [ fhir:v "Particle size distribution" ] ] [ fhir:code [ fhir:v "Lyophilization Water Homogeneity" ] ; fhir:display [ fhir:v "Lyophilization Water Homogeneity" ] ] [ fhir:code [ fhir:v "Lyophilization Assay Homogeneity" ] ; fhir:display [ fhir:v "Lyophilization Assay Homogeneity" ] ] [ fhir:code [ fhir:v "Particle Size RSD" ] ; fhir:display [ fhir:v "Particle Size RSD" ] ] [ fhir:code [ fhir:v "Obscuration" ] ; fhir:display [ fhir:v "Obscuration" ] ] [ fhir:code [ fhir:v "Refractive index" ] ; fhir:display [ fhir:v "Refractive index" ] ] [ fhir:code [ fhir:v "ElementalAnalysisCarbon" ] ; fhir:display [ fhir:v "Elemental Analysis Carbon (%)" ] ] [ fhir:code [ fhir:v "IonAnalysisCarbonMass" ] ; fhir:display [ fhir:v "Ion Analysis Carbon - Mass" ] ] [ fhir:code [ fhir:v "IonAnalysisCarbonMassAccuracy" ] ; fhir:display [ fhir:v "Ion Analysis Carbon - Mass Accuracy" ] ] [ fhir:code [ fhir:v "IonAnalysisCarbon" ] ; fhir:display [ fhir:v "Ion Analysis Carbon (%)" ] ] [ fhir:code [ fhir:v "ElementalAnalysisHydrogen" ] ; fhir:display [ fhir:v "Elemental Analysis Hydrogen (%)" ] ] [ fhir:code [ fhir:v "IonAnalysisHydrogenMass" ] ; fhir:display [ fhir:v "Ion Analysis Hydrogen - Mass" ] ] [ fhir:code [ fhir:v "IonAnalysisHydrogenMassAccuracy" ] ; fhir:display [ fhir:v "Ion Analysis Hydrogen - Mass Accuracy" ] ] [ fhir:code [ fhir:v "IonAnalysisHydrogen" ] ; fhir:display [ fhir:v "Ion Analysis Hydrogen (%)" ] ] [ fhir:code [ fhir:v "ElementalAnalysisNitrogen" ] ; fhir:display [ fhir:v "Elemental Analysis Nitrogen (%)" ] ] [ fhir:code [ fhir:v "IonAnalysisNitrogen" ] ; fhir:display [ fhir:v "Ion Analysis Nitrogen (%)" ] ] [ fhir:code [ fhir:v "IonAnalysisNitrogenMass" ] ; fhir:display [ fhir:v "Ion Analysis Nitrogen - Mass" ] ] [ fhir:code [ fhir:v "IonAnalysisNitrogenMassAccuracy" ] ; fhir:display [ fhir:v "Ion Analysis Nitrogen - Mass Accuracy" ] ] [ fhir:code [ fhir:v "ElementalAnalysisFlourine" ] ; fhir:display [ fhir:v "Elemental Analysis Flourine (%)" ] ] [ fhir:code [ fhir:v "IonAnalysisFlourine" ] ; fhir:display [ fhir:v "Ion Analysis Flourine (%)" ] ] [ fhir:code [ fhir:v "IonAnalysisFlourineMass" ] ; fhir:display [ fhir:v "Ion Analysis Flourine - Mass" ] ] [ fhir:code [ fhir:v "IonAnalysisFlourineMassAccuracy" ] ; fhir:display [ fhir:v "Ion Analysis Flourine - Mass Accuracy" ] ] [ fhir:code [ fhir:v "Chemical Structure" ] ; fhir:display [ fhir:v "Chemical Structure" ] ] [ fhir:code [ fhir:v "Diffractogram" ] ; fhir:display [ fhir:v "Diffractogram" ] ] [ fhir:code [ fhir:v "MolecularStructure" ] ; fhir:display [ fhir:v "Molecular Structure" ] ] [ fhir:code [ fhir:v "Absorption" ] ; fhir:display [ fhir:v "Absorption" ] ] [ fhir:code [ fhir:v "X-Ray Powder Diffractogram" ] ; fhir:display [ fhir:v "X-Ray Powder Diffractogram" ] ] [ fhir:code [ fhir:v "pH (post-dilution bulk solution)" ] ; fhir:display [ fhir:v "pH (post-dilution bulk solution)" ] ] [ fhir:code [ fhir:v "Appearance (Product Container, visual)" ] ; fhir:display [ fhir:v "Appearance (Product Container, visual)" ] ] [ fhir:code [ fhir:v "Appearance (Lyophilized, Visual)" ] ; fhir:display [ fhir:v "Appearance (Lyophilized, Visual)" ] ] [ fhir:code [ fhir:v "Appearance (Reconstituted, Visual)" ] ; fhir:display [ fhir:v "Appearance (Reconstituted, Visual)" ] ] [ fhir:code [ fhir:v "Appearance" ] ; fhir:display [ fhir:v "Appearance" ] ] [ fhir:code [ fhir:v "pH (reconstituted)" ] ; fhir:display [ fhir:v "pH (reconstituted)" ] ] [ fhir:code [ fhir:v "TAMC" ] ; fhir:display [ fhir:v "TAMC" ] ] [ fhir:code [ fhir:v "Fill Weight Average" ] ; fhir:display [ fhir:v "Fill Weight Average" ] ] [ fhir:code [ fhir:v "Fill Weight Target (g)" ] ; fhir:display [ fhir:v "Fill Weight Target (g)" ] ] [ fhir:code [ fhir:v "Actual Avg. Weight from Target" ] ; fhir:display [ fhir:v "Actual Avg. Weight from Target" ] ] [ fhir:code [ fhir:v "Hold Time (filtration To filling)" ] ; fhir:display [ fhir:v "Hold Time (filtration To filling)" ] ] [ fhir:code [ fhir:v "Hold Time (start filling to end filling)" ] ; fhir:display [ fhir:v "Hold Time (start filling to end filling)" ] ] [ fhir:code [ fhir:v "Filter Integrity Test" ] ; fhir:display [ fhir:v "Filter Integrity Test" ] ] [ fhir:code [ fhir:v "Lyophilizer Number" ] ; fhir:display [ fhir:v "Lyophilizer Number" ] ] [ fhir:code [ fhir:v "pH (adjustment of pre-clarification bulk solution)" ] ; fhir:display [ fhir:v "pH (adjustment of pre-clarification bulk solution)" ] ] [ fhir:code [ fhir:v "Assay (pre-clarification filtration) (mg/mL)" ] ; fhir:display [ fhir:v "Assay (pre-clarification filtration) (mg/mL)" ] ] [ fhir:code [ fhir:v "Assay (Post dilution bulk solution) (mg/mL)" ] ; fhir:display [ fhir:v "Assay (Post dilution bulk solution) (mg/mL)" ] ] [ fhir:code [ fhir:v "Test Date" ] ; fhir:display [ fhir:v "Test Date" ] ] [ fhir:code [ fhir:v "Identification (NMR)" ] ; fhir:display [ fhir:v "Identification (NMR)" ] ] [ fhir:code [ fhir:v "Identification (FT-IR)" ] ; fhir:display [ fhir:v "Identification (FT-IR)" ] ] [ fhir:code [ fhir:v "VisualInspection" ] ; fhir:display [ fhir:v "VisualInspection" ] ] [ fhir:code [ fhir:v "InfraredSpectroscopy" ] ; fhir:display [ fhir:v "InfraredSpectroscopy" ] ] [ fhir:code [ fhir:v "SupplierCertificateofAnalysis" ] ; fhir:display [ fhir:v "SupplierCertificateofAnalysis" ] ] [ fhir:code [ fhir:v "Elemental" ] ; fhir:display [ fhir:v "Elemental" ] ] [ fhir:code [ fhir:v "Uniformity of Dosage Units, Weight Variation" ] ; fhir:display [ fhir:v "Uniformity of Dosage Units, Weight Variation" ] ] [ fhir:code [ fhir:v "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)" ] ; fhir:display [ fhir:v "Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV)" ] ] [ fhir:code [ fhir:v "Yield (%)" ] ; fhir:display [ fhir:v "Yield (%)" ] ] [ fhir:code [ fhir:v "ResidualWaterContent" ] ; fhir:display [ fhir:v "Residual Water Content (w/w%)" ] ] [ fhir:code [ fhir:v "Reaction conversion: Residual Starting Material 1 by HPLC" ] ; fhir:display [ fhir:v "Reaction conversion: Residual Starting Material 1 by HPLC" ] ] [ fhir:code [ fhir:v "Bacterial Endotoxins (EU/mL)" ] ; fhir:display [ fhir:v "Bacterial Endotoxins (EU/mL)" ] ] [ fhir:code [ fhir:v "Bioburden - Beginning" ] ; fhir:display [ fhir:v "Bioburden - Beginning" ] ] [ fhir:code [ fhir:v "Bioburden - End" ] ; fhir:display [ fhir:v "Bioburden - End" ] ] [ fhir:code [ fhir:v "Bioburden (CFU/ 100 mL)" ] ; fhir:display [ fhir:v "Bioburden (CFU/ 100 mL)" ] ] [ fhir:code [ fhir:v "Buffer vessel mixing speed (rpm)" ] ; fhir:display [ fhir:v "Buffer vessel mixing speed (rpm)" ] ] [ fhir:code [ fhir:v "Buffer vessel mixing time (min)" ] ; fhir:display [ fhir:v "Buffer vessel mixing time (min)" ] ] [ fhir:code [ fhir:v "CONC" ] ; fhir:display [ fhir:v "Conclusion" ] ] [ fhir:code [ fhir:v "Conductivity (μS/cm)" ] ; fhir:display [ fhir:v "Conductivity (μS/cm)" ] ] [ fhir:code [ fhir:v "Fill Weight" ] ; fhir:display [ fhir:v "Fill Weight" ] ] [ fhir:code [ fhir:v "Fill Weight - Maximum" ] ; fhir:display [ fhir:v "Fill Weight - Maximum" ] ] [ fhir:code [ fhir:v "Fill Weight - Mean" ] ; fhir:display [ fhir:v "Fill Weight - Mean" ] ] [ fhir:code [ fhir:v "Fill Weight - Minimum" ] ; fhir:display [ fhir:v "Fill Weight - Minimum" ] ] [ fhir:code [ fhir:v "FiltrationPressure (psig)" ] ; fhir:display [ fhir:v "FiltrationPressure (psig)" ] ] [ fhir:code [ fhir:v "Formulation vessel mixing speed (rpm)" ] ; fhir:display [ fhir:v "Formulation vessel mixing speed (rpm)" ] ] [ fhir:code [ fhir:v "Formulation vessel mixing time (min)" ] ; fhir:display [ fhir:v "Formulation vessel mixing time (min)" ] ] [ fhir:code [ fhir:v "Growth Promotion - Beginning" ] ; fhir:display [ fhir:v "Growth Promotion - Beginning" ] ] [ fhir:code [ fhir:v "Growth Promotion - End" ] ; fhir:display [ fhir:v "Growth Promotion - End" ] ] [ fhir:code [ fhir:v "GrowthPromotion" ] ; fhir:display [ fhir:v "Growth Promotion" ] ] [ fhir:code [ fhir:v "Hold Time" ] ; fhir:display [ fhir:v "Hold Time" ] ] [ fhir:code [ fhir:v "LyophilizationHomogeneneity" ] ; fhir:display [ fhir:v "Lyophilization Homogeneneity" ] ] [ fhir:code [ fhir:v "Media Challenge Hold Times" ] ; fhir:display [ fhir:v "Media Challenge Hold Times" ] ] [ fhir:code [ fhir:v "MediaChallengeRun" ] ; fhir:display [ fhir:v "Media Challenge Run" ] ] [ fhir:code [ fhir:v "Osmolality" ] ; fhir:display [ fhir:v "Osmolality" ] ] [ fhir:code [ fhir:v "OVERALLSAMP" ] ; fhir:display [ fhir:v "Number of Samples" ] ] [ fhir:code [ fhir:v "particle-size" ] ; fhir:display [ fhir:v "Particle Size" ] ] [ fhir:code [ fhir:v "pH" ] ; fhir:display [ fhir:v "pH" ] ] [ fhir:code [ fhir:v "Polysorbate 80 (% w/v)" ] ; fhir:display [ fhir:v "Polysorbate 80 (% w/v)" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration - Beginning - Max" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration - Beginning - Max" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration - Beginning - Min" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration - Beginning - Min" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration - End - Max" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration - End - Max" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration - End - Min" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration - End - Min" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration - Middle - Max" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration - Middle - Max" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration - Middle - Min" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration - Middle - Min" ] ] [ fhir:code [ fhir:v "Polysorbate 80 concentration (% w/v)" ] ; fhir:display [ fhir:v "Polysorbate 80 concentration (% w/v)" ] ] [ fhir:code [ fhir:v "Post-filtration Filter Integrity (psig)" ] ; fhir:display [ fhir:v "Post-filtration Filter Integrity (psig)" ] ] [ fhir:code [ fhir:v "Pre-filtration Bioburden (CFU/ 100 mL)" ] ; fhir:display [ fhir:v "Pre-filtration Bioburden (CFU/ 100 mL)" ] ] [ fhir:code [ fhir:v "Protein Concentration (mg/mL)" ] ; fhir:display [ fhir:v "Protein Concentration (mg/mL)" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - End - Higher" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - End - Higher" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - End - Lower" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - End - Lower" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - End - Mean" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - End - Mean" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - Max" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - Max" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - Middle - Higher" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - Middle - Higher" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - Middle - Lower" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - Middle - Lower" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - Middle - Mean" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - Middle - Mean" ] ] [ fhir:code [ fhir:v "Protein Concentration - Beginning - Min" ] ; fhir:display [ fhir:v "Protein Concentration - Beginning - Min" ] ] [ fhir:code [ fhir:v "Protein Concentration - Conclusion" ] ; fhir:display [ fhir:v "Protein Concentration - Conclusion" ] ] [ fhir:code [ fhir:v "Protein Concentration - End - Max" ] ; fhir:display [ fhir:v "Protein Concentration - End - Max" ] ] [ fhir:code [ fhir:v "Protein Concentration - End - Min" ] ; fhir:display [ fhir:v "Protein Concentration - End - Min" ] ] [ fhir:code [ fhir:v "Protein Concentration - Middle - End - Higher" ] ; fhir:display [ fhir:v "Protein Concentration - Middle - End - Higher" ] ] [ fhir:code [ fhir:v "Protein Concentration - Middle - End - Lower" ] ; fhir:display [ fhir:v "Protein Concentration - Middle - End - Lower" ] ] [ fhir:code [ fhir:v "Protein Concentration - Middle - End - Mean" ] ; fhir:display [ fhir:v "Protein Concentration - Middle - End - Mean" ] ] [ fhir:code [ fhir:v "Protein Concentration - Middle - Max" ] ; fhir:display [ fhir:v "Protein Concentration - Middle - Max" ] ] [ fhir:code [ fhir:v "Protein Concentration - Middle - Min" ] ; fhir:display [ fhir:v "Protein Concentration - Middle - Min" ] ] [ fhir:code [ fhir:v "Protein Concentration Statistics" ] ; fhir:display [ fhir:v "Protein Concentration Statistics" ] ] [ fhir:code [ fhir:v "Residual Moisture - Max" ] ; fhir:display [ fhir:v "Residual Moisture - Max" ] ] [ fhir:code [ fhir:v "Residual Moisture - Min" ] ; fhir:display [ fhir:v "Residual Moisture - Min" ] ] [ fhir:code [ fhir:v "Residual Moisture" ] ; fhir:display [ fhir:v "Residual Moisture" ] ] [ fhir:code [ fhir:v "SE-UHPLC Main Peak - Beginning" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak - Beginning" ] ] [ fhir:code [ fhir:v "SE-UHPLC HMW - Conclusion" ] ; fhir:display [ fhir:v "SE-UHPLC HMW - Conclusion" ] ] [ fhir:code [ fhir:v "SE-UHPLC Main Peak - Conclusion" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak - Conclusion" ] ] [ fhir:code [ fhir:v "SE-UHPLC Main Peak - End" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak - End" ] ] [ fhir:code [ fhir:v "SE-UHPLCHMW - Beginning" ] ; fhir:display [ fhir:v "SE-UHPLC HMW - Beginning" ] ] [ fhir:code [ fhir:v "SE-UHPLCHMW - End" ] ; fhir:display [ fhir:v "SE-UHPLC HMW - End" ] ] [ fhir:code [ fhir:v "SE-UHPLCHMWPeak - Conclusion" ] ; fhir:display [ fhir:v "SE-UHPLC HMW Peak - Conclusion" ] ] [ fhir:code [ fhir:v "SE-UHPLCHMW" ] ; fhir:display [ fhir:v "SE-UHPLC HMW" ] ] [ fhir:code [ fhir:v "SE-UHPLCMainPeak - Conclusion" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak - Conclusion" ] ] [ fhir:code [ fhir:v "SE-UHPLCMainPeak" ] ; fhir:display [ fhir:v "SE-UHPLC Main Peak" ] ] [ fhir:code [ fhir:v "test-success" ] ; fhir:display [ fhir:v "Test Success" ] ] [ fhir:code [ fhir:v "Thaw Time" ] ; fhir:display [ fhir:v "Thaw Time" ] ] [ fhir:code [ fhir:v "Thawing Temp" ] ; fhir:display [ fhir:v "Thawing Temp" ] ] [ fhir:code [ fhir:v "WaterContent" ] ; fhir:display [ fhir:v "Water content" ] ] [ fhir:code [ fhir:v "AssignedPurity" ] ; fhir:display [ fhir:v "Assigned Purity" ] ] ) . #
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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