| Code | Display |
| ionic-strength | Ionic Strength |
| physicochemical | Physicochemical properties |
| SE-UHPLCHMW-15 | SE-UHPLC HMW - 15 |
| SE-UHPLCHMW-25 | SE-UHPLC HMW - 25 |
| SE-UHPLCMainPeak-15 | SE-UHPLC Main Peak - 15 |
| SE-UHPLCMainPeak-25 | SE-UHPLC Main Peak - 25 |
| SIZE | Particle Size |
| SOL | Residual solvents |
| SOLV | Solvent |
| SSE | Statistically significant effects |
| TEMP | Temperature |
| UCL | Upper one-sided 95% confidence limit of Max Difference |
| uniformity-dosage | uniformity of dosage units (by weight) |
| WWWH | Water Content Homogeneity |
| SAMP | Number of Samples |
| DGP | Degradation Products |
| DGP-s | Drug Substance Related Organic impurities |
| IMP | Impurity |
| Impurities | Impurities |
| WWW | Water Content |
| Microbiological Quality | Microbiological Quality |
| ASSAY | Assay |
| CEX-HPLCAcidicPeak | CEX-HPLC Acidic Peak |
| CEX-HPLCMainPeak | CEX-HPLC Main Peak |
| PART | Particle size distribution |
| ASSH | Assay Content Homogeneity |
| DESC | Description |
| Dissolution | Dissolution |
| Dissolution Quantity | Dissolution Quantity |
| ELE | Elemental impurities |
| enantiomeric-purity | Enantiomeric purity |
| IDT | Identification |
| MUT | Mutagenic impurities |
| NMR | NMR |
| NMR-C | NMR-C |
| NMR-H | NMR-H |
| CEX-HPLCAcidicPeak-15 | CEX-HPLC Acidic Peak - 15 |
| CEX-HPLCAcidicPeak-25 | CEX-HPLC Acidic Peak - 25 |
| CEX-HPLCMainPeak-15 | CEX-HPLC Main Peak - 15 |
| CEX-HPLCMainPeak-25 | CEX-HPLC Main Peak - 25 |
| Homogeneity | Homogeneity demonstrated |
| LCL | Lower one-sided 95% confidence limit of Max Difference |
| LOC | Number of Locations |
| PARTS | Particle size |
| POS | Structure Position |
| particle-size-distribution | Particle size distribution |
| Lyophilization Water Homogeneity | Lyophilization Water Homogeneity |
| Lyophilization Assay Homogeneity | Lyophilization Assay Homogeneity |
| Particle Size RSD | Particle Size RSD |
| Obscuration | Obscuration |
| Refractive index | Refractive index |
| ElementalAnalysisCarbon | Elemental Analysis Carbon (%) |
| IonAnalysisCarbonMass | Ion Analysis Carbon - Mass |
| IonAnalysisCarbonMassAccuracy | Ion Analysis Carbon - Mass Accuracy |
| IonAnalysisCarbon | Ion Analysis Carbon (%) |
| ElementalAnalysisHydrogen | Elemental Analysis Hydrogen (%) |
| IonAnalysisHydrogenMass | Ion Analysis Hydrogen - Mass |
| IonAnalysisHydrogenMassAccuracy | Ion Analysis Hydrogen - Mass Accuracy |
| IonAnalysisHydrogen | Ion Analysis Hydrogen (%) |
| ElementalAnalysisNitrogen | Elemental Analysis Nitrogen (%) |
| IonAnalysisNitrogen | Ion Analysis Nitrogen (%) |
| IonAnalysisNitrogenMass | Ion Analysis Nitrogen - Mass |
| IonAnalysisNitrogenMassAccuracy | Ion Analysis Nitrogen - Mass Accuracy |
| ElementalAnalysisFlourine | Elemental Analysis Flourine (%) |
| IonAnalysisFlourine | Ion Analysis Flourine (%) |
| IonAnalysisFlourineMass | Ion Analysis Flourine - Mass |
| IonAnalysisFlourineMassAccuracy | Ion Analysis Flourine - Mass Accuracy |
| Chemical Structure | Chemical Structure |
| Diffractogram | Diffractogram |
| MolecularStructure | Molecular Structure |
| Absorption | Absorption |
| X-Ray Powder Diffractogram | X-Ray Powder Diffractogram |
| pH (post-dilution bulk solution) | pH (post-dilution bulk solution) |
| Appearance (Product Container, visual) | Appearance (Product Container, visual) |
| Appearance (Lyophilized, Visual) | Appearance (Lyophilized, Visual) |
| Appearance (Reconstituted, Visual) | Appearance (Reconstituted, Visual) |
| Appearance | Appearance |
| pH (reconstituted) | pH (reconstituted) |
| TAMC | TAMC |
| Fill Weight Average | Fill Weight Average |
| Fill Weight Target (g) | Fill Weight Target (g) |
| Actual Avg. Weight from Target | Actual Avg. Weight from Target |
| Hold Time (filtration To filling) | Hold Time (filtration To filling) |
| Hold Time (start filling to end filling) | Hold Time (start filling to end filling) |
| Filter Integrity Test | Filter Integrity Test |
| Lyophilizer Number | Lyophilizer Number |
| pH (adjustment of pre-clarification bulk solution) | pH (adjustment of pre-clarification bulk solution) |
| Assay (pre-clarification filtration) (mg/mL) | Assay (pre-clarification filtration) (mg/mL) |
| Assay (Post dilution bulk solution) (mg/mL) | Assay (Post dilution bulk solution) (mg/mL) |
| Test Date | Test Date |
| Identification (NMR) | Identification (NMR) |
| Identification (FT-IR) | Identification (FT-IR) |
| VisualInspection | VisualInspection |
| InfraredSpectroscopy | InfraredSpectroscopy |
| SupplierCertificateofAnalysis | SupplierCertificateofAnalysis |
| Elemental | Elemental |
| Uniformity of Dosage Units, Weight Variation | Uniformity of Dosage Units, Weight Variation |
| Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) | Uniformity of Dosage Units, Weight Variation - Acceptance Value (AV) |
| Yield (%) | Yield (%) |
| ResidualWaterContent | Residual Water Content (w/w%) |
| Reaction conversion: Residual Starting Material 1 by HPLC | Reaction conversion: Residual Starting Material 1 by HPLC |
| Bacterial Endotoxins (EU/mL) | Bacterial Endotoxins (EU/mL) |
| Bioburden - Beginning | Bioburden - Beginning |
| Bioburden - End | Bioburden - End |
| Bioburden (CFU/ 100 mL) | Bioburden (CFU/ 100 mL) |
| Buffer vessel mixing speed (rpm) | Buffer vessel mixing speed (rpm) |
| Buffer vessel mixing time (min) | Buffer vessel mixing time (min) |
| CONC | Conclusion |
| Conductivity (μS/cm) | Conductivity (μS/cm) |
| Fill Weight | Fill Weight |
| Fill Weight - Maximum | Fill Weight - Maximum |
| Fill Weight - Mean | Fill Weight - Mean |
| Fill Weight - Minimum | Fill Weight - Minimum |
| FiltrationPressure (psig) | FiltrationPressure (psig) |
| Formulation vessel mixing speed (rpm) | Formulation vessel mixing speed (rpm) |
| Formulation vessel mixing time (min) | Formulation vessel mixing time (min) |
| Growth Promotion - Beginning | Growth Promotion - Beginning |
| Growth Promotion - End | Growth Promotion - End |
| GrowthPromotion | Growth Promotion |
| Hold Time | Hold Time |
| LyophilizationHomogeneneity | Lyophilization Homogeneneity |
| Media Challenge Hold Times | Media Challenge Hold Times |
| MediaChallengeRun | Media Challenge Run |
| Osmolality | Osmolality |
| OVERALLSAMP | Number of Samples |
| particle-size | Particle Size |
| pH | pH |
| Polysorbate 80 (% w/v) | Polysorbate 80 (% w/v) |
| Polysorbate 80 concentration - Beginning - Max | Polysorbate 80 concentration - Beginning - Max |
| Polysorbate 80 concentration - Beginning - Min | Polysorbate 80 concentration - Beginning - Min |
| Polysorbate 80 concentration - End - Max | Polysorbate 80 concentration - End - Max |
| Polysorbate 80 concentration - End - Min | Polysorbate 80 concentration - End - Min |
| Polysorbate 80 concentration - Middle - Max | Polysorbate 80 concentration - Middle - Max |
| Polysorbate 80 concentration - Middle - Min | Polysorbate 80 concentration - Middle - Min |
| Polysorbate 80 concentration (% w/v) | Polysorbate 80 concentration (% w/v) |
| Post-filtration Filter Integrity (psig) | Post-filtration Filter Integrity (psig) |
| Pre-filtration Bioburden (CFU/ 100 mL) | Pre-filtration Bioburden (CFU/ 100 mL) |
| Protein Concentration (mg/mL) | Protein Concentration (mg/mL) |
| Protein Concentration - Beginning - End - Higher | Protein Concentration - Beginning - End - Higher |
| Protein Concentration - Beginning - End - Lower | Protein Concentration - Beginning - End - Lower |
| Protein Concentration - Beginning - End - Mean | Protein Concentration - Beginning - End - Mean |
| Protein Concentration - Beginning - Max | Protein Concentration - Beginning - Max |
| Protein Concentration - Beginning - Middle - Higher | Protein Concentration - Beginning - Middle - Higher |
| Protein Concentration - Beginning - Middle - Lower | Protein Concentration - Beginning - Middle - Lower |
| Protein Concentration - Beginning - Middle - Mean | Protein Concentration - Beginning - Middle - Mean |
| Protein Concentration - Beginning - Min | Protein Concentration - Beginning - Min |
| Protein Concentration - Conclusion | Protein Concentration - Conclusion |
| Protein Concentration - End - Max | Protein Concentration - End - Max |
| Protein Concentration - End - Min | Protein Concentration - End - Min |
| Protein Concentration - Middle - End - Higher | Protein Concentration - Middle - End - Higher |
| Protein Concentration - Middle - End - Lower | Protein Concentration - Middle - End - Lower |
| Protein Concentration - Middle - End - Mean | Protein Concentration - Middle - End - Mean |
| Protein Concentration - Middle - Max | Protein Concentration - Middle - Max |
| Protein Concentration - Middle - Min | Protein Concentration - Middle - Min |
| Protein Concentration Statistics | Protein Concentration Statistics |
| Residual Moisture - Max | Residual Moisture - Max |
| Residual Moisture - Min | Residual Moisture - Min |
| Residual Moisture | Residual Moisture |
| SE-UHPLC Main Peak - Beginning | SE-UHPLC Main Peak - Beginning |
| SE-UHPLC HMW - Conclusion | SE-UHPLC HMW - Conclusion |
| SE-UHPLC Main Peak - Conclusion | SE-UHPLC Main Peak - Conclusion |
| SE-UHPLC Main Peak - End | SE-UHPLC Main Peak - End |
| SE-UHPLCHMW - Beginning | SE-UHPLC HMW - Beginning |
| SE-UHPLCHMW - End | SE-UHPLC HMW - End |
| SE-UHPLCHMWPeak - Conclusion | SE-UHPLC HMW Peak - Conclusion |
| SE-UHPLCHMW | SE-UHPLC HMW |
| SE-UHPLCMainPeak - Conclusion | SE-UHPLC Main Peak - Conclusion |
| SE-UHPLCMainPeak | SE-UHPLC Main Peak |
| test-success | Test Success |
| Thaw Time | Thaw Time |
| Thawing Temp | Thawing Temp |
| WaterContent | Water content |
| AssignedPurity | Assigned Purity |
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