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 |