Exact(4)
'Spectral (1H and 13C) NMR characterization data, copies of the respective spectra for compounds 4, 5 and 1, as well as a Quality Control (QC) report on a representative batch of atorvastatin calcium can be found online as Additional Material for the present article'.
A representative batch pretreatment of CEL at 140°C (T rxtr ) is described; this procedure was repeated according to the conditions described in Table 3.
A representative batch of ZERA-GLA was chosen as a positive control and quantification standard by first quantifying against a commercial GLA from E. coli 12078-H08H (Sino Biological Inc. Beijing, China) using GelCode Blue G250 Coomassie stain (Thermo).
A representative batch pH adjustment to produce 2 kg of 20% total solids (factoring in the enzyme dosing) pH 5.0 WS consisted of diluting 1.2 kg of WS at total solids approximately 32% w/w to a final total solids level of 20% (w/w) using a combination of NH4OH (approximately 32.0 ml NH4OH per 1200 g WS) and sterile deionized water.
Similar(56)
RhFVIIa originating from a representative pilot batch has been used for structural characterization.
The study described in this article aims at explaining the raw material variability of an API using extensive material characterization on a restricted number of representative batches using multivariate data analysis.
The mean and standard deviation of BG per NPCP was calculated from 4 independent representative batches.
The NP-HPLC profiles of the fluorescently labelled N-glycan pool from representative batches of imiglucerase and velaglucerase alfa can be seen in Figures 1(B) and 1(C), respectively.
The NP-HPLC profiles of the fluorescently labelled N-glycan pool from a representative taliglucerase alfa batch, released by PNGase A are shown in Figure 1(A).
In-plate control values within a representative 50-plate batch run (3D7 strain) were plotted and showed stability of the assay window with minimal intraplate variation.
A prototype implementation is discussed using a representative example of 3 batch extruders processing orders for 4 different products.
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