Method comprises placing, in a cuvette, a length l sample which is subjected to heating from the edge of the cuvette or to the action of active initiators for the appearance of peroxide compounds, causing the spread of the oxidation zone of the substance along the length of the cuvette at...
indicating method are also described. Case studies of challenging HPLC method development on dual drug systems in solid dosage and surfactants with different molecular weights in liquid formulation are presented. Stability testing is an integral part of pharmaceutical product development and is ongoing ...
Forced degradation studies are also useful for drug candidate selection, stability indicating method development, formulation and manufacturing process development, and understanding the degradation pathways. Factors to consider for forced degradation studies include pH, temperature, light, oxidizing agents, mec...
stability indicating assay/degradation product method to monitor structural changes (typically covalent changes) in the organic component of the drug substance. This is most commonly done with a stability-indicating HPLC or UPLC method. Typically, UV detection is utilized, but mass spectrometry, ...
AL had the lowest MCC value, indicating that the clustering of many sequences pairs changed when using this method. Alternatively, SL produced a higher MCC value than most of the de novo methods, including AL and CL. Nevertheless, part of the reason for the high MCC value of SL is that...
Stabilitystudiesshouldincludetestingofthoseattributesofthedrugsubstancethataresusceptibletochangeduringstorageandarelikelytoinfluencequality,safety,and/orefficacy.Thetestingshouldcover,asappropriate,thephysical,chemical,biological,andmicrobiologicalattributes.Validatedstability-indicatinganalyticalproceduresshouldbeapplied.Whether...
well within the 1σconfidence interval ranging from 2.4% relative humidity to 26% relative humidity. Varying both temperature and relative humidity, the solid–solid phase diagram indicating the most stable form as a function of the thermodynamic variables can be constructed as shown in Fig.6. The...
Furthermore, one immediately observes that T has singularities at those points where [Math Processing Error]z=−Ni∗, indicating that the region containing the eigenvalues of S must necessarily envelope the population equilibria −[Math Processing Error]Ni∗. This gives an important hint of ...
(\lambda _1\)for the permuted dispersal metacommunities are greater than the corresponding original metacommunity, indicating that the permuted metacommunities are typically less stable. Points that lie below the 1:1 line represent cases where the permuted metacommunities are typically more stable. ...
indicating the attractor strength. However, especially for the intermediate group in Experiment 2, the sample size was small and normality was not confirmed. Therefore, in Experiment 2, significance was tested using a nonparametric method. In order to confirm the validity of the results, it is ...