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Capsules stability program

Forced degradation studies are carried out either in the solution state and/or in the solid state. Usually the forced degradation testing is carried out on one batch of drug substance and/or one formulation blend (capsules and tablets). This forced degradation testing should not be part of a formal stability program. [Pg.492]

No data have yet been published on the stability of CLA in capsules. Observations on polymers and volatiles in capsules are reported above. In a stability test program according to International Conference on Harmonization (ICH) guidelines on a free fatty acid product, the content of total CLA was not significantly reduced after 24 mo at 25°C/60% relative humidity. In this test, CLA was measured by GC. Peroxide value (PV) did not develop in the capsules (data not published). [Pg.85]


See other pages where Capsules stability program is mentioned: [Pg.462]    [Pg.55]    [Pg.36]    [Pg.604]    [Pg.99]    [Pg.413]    [Pg.988]    [Pg.345]    [Pg.250]    [Pg.197]    [Pg.150]    [Pg.123]   
See also in sourсe #XX -- [ Pg.204 , Pg.205 , Pg.215 ]




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Capsule stability

Stability program

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