Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Degradation studies forced

Acid stability Base stability Light stability [Pg.81]

Lab and factory manufacturing Accelerated storage conditions Ambient environment as well as formulation Plasma [Pg.81]

Heat and/or moisture stability Oxidative stability Plasma stability [Pg.81]

Finally, the developed HPLC method needs to have suitable mass balance based on major degradants. [Pg.82]

Identifying the degradants is very important to understand the potential degradation pathways. LC-MS, LC-MS/MS, and LC-NMR are commonly used to help study the structures ofthe degradation products. [Pg.82]

Reynolds, D.W., Fachine, K.L., Mullaney, J.F., Alsante, K.M., Hatajik, T.D., and Moto, G.M., Available guidance and best practices for conducting forced degradation studies, Pharm. Technol., February, 48, 2002. [Pg.48]

TABLE 3 Suggested Conditions for Performing Forced Degradation Studies... [Pg.200]

It is common practice to utilize forced degradation studies to accelerate degradation of the drug substance or drug product to get an understanding of its degradation profile. Potential environmental conditions that can be used include 40°C and 75% relative humidity (RH), 50°C and 75% RH, 70°C and 75% RH, or 80°C and 75% RH. Oxidation, reduction, and pH-related degradations are... [Pg.15]

Ruan, J., Tattersall, P, Lozano, R., and Shah, P. (2006). The role of forced degradation studies in stability indicating HPLC method developmerWm. Pharm. Rev., 9, 463. [Pg.89]

Recent publications on the topic of stress testing/forced degradation studies reveal that there is still a tremendous variability in the conditions... [Pg.7]

As described in the PhRMA Available Guidance and Best Practices article on forced degradation studies (12), stress testing should include condi-... [Pg.19]

Reynolds DW. Available regulatory guidance and best practices for conducting forced degradation studies. Forced Degradation Studies Best Practices for the Pharmaceutical Industry. Institute for International Research, Princeton, NJ, Feb 24-25, 2004. [Pg.47]

As mentioned in the Introduction, ICH describes two kinds of tests for drug photostability determination (1) forced degradation studies and (2) confirmatory studies . ICH describes two options for light sources for use in confirmatory studies (1). [Pg.310]

Table 1 General Protocol for Forced Degradation Studies (Stress Testing) of Drug Substance and Drug Products... Table 1 General Protocol for Forced Degradation Studies (Stress Testing) of Drug Substance and Drug Products...
Forced degradation/stress studies elucidate the inherent stability characteristics of the molecule under study and determine its degradative pathways. Forced degradation studies are needed to support method validation, determine product protection requirements, and guide formulation development. [Pg.192]

A comprehensive literature search should be carried out before initiating any laboratory work related to forced degradation studies. Such a search may uncover the needed information if the API is a well-known entity or guide the choice of conditions to be used if information is available for related compounds. [Pg.192]

See other pages where Degradation studies forced is mentioned: [Pg.264]    [Pg.248]    [Pg.250]    [Pg.24]    [Pg.200]    [Pg.338]    [Pg.345]    [Pg.350]    [Pg.351]    [Pg.366]    [Pg.369]    [Pg.369]    [Pg.535]    [Pg.126]    [Pg.574]    [Pg.658]    [Pg.683]    [Pg.38]    [Pg.81]    [Pg.81]    [Pg.82]    [Pg.7]    [Pg.29]    [Pg.42]    [Pg.294]    [Pg.312]    [Pg.313]    [Pg.314]    [Pg.316]    [Pg.317]    [Pg.420]   
See also in sourсe #XX -- [ Pg.224 ]

See also in sourсe #XX -- [ Pg.60 , Pg.61 , Pg.62 , Pg.63 , Pg.64 , Pg.65 , Pg.66 , Pg.67 , Pg.68 , Pg.69 , Pg.70 , Pg.71 , Pg.72 , Pg.73 , Pg.74 , Pg.75 , Pg.76 , Pg.77 , Pg.78 ]



SEARCH



Degradation studies

Degradative studies

© 2024 chempedia.info