Batch Records
Results based on QC Visual Appearance Test
Antimicrobial effectiveness test: only for Antibiotics
Chemical composition of impurities
USP <788> Particulate Matter test: (NMT = No More Than) x particles per container, per size
Variability of Fill volume (RSD = Relative Standard Deviation) in 10 sampled units
Chemical Identification via HPLC: retention time matches identified drug characteristics
Chemical composition of active ingredient in compound
Acidity of solution, based on typical characteristics
Fill volume in given containers
(EU = Endotoxin Units) ≤USP <85> defined limits
USP <71> media fill test results, 14 day
