Analysis of semisolid dosage forms
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The following quality attributes of semisolid dosage forms of drugs, such as ointments and creams, are evaluated:
Analysis of
semisolid dosage forms
The
following quality attributes of semisolid dosage forms of drugs, such as
ointments and creams, are evaluated:
1.
Physical stability, in terms of nonseparation of emulsion
phases, when applicable, and homogeneity of appearance/color.
2.
Drug identity, purity, content, and uniformity of content.
The content of drug per unit mass of the dosage form and impurities/related
sub-stances of the drug substance indicate its potency and purity.
3.
Drug release rate using an in vitro test.
4.
Viscosity of the formulation.
5.
Minimum fill in the container and deliverable volume or
doses.
6.
Although these dosage forms are not required to be sterile,
the micro-bial content of certain bacterial species, such as Staphylococcus aureus and Pseudomonas
aeruginosa, is controlled.
