| 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 |
| 1d2344 |
Tape |
| 200000003208 |
Plastic |
| 112344ss |
PVC |
|
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