Study Set: QC chapter 2

Quality Standards and Compendial Requirements for Semi-Solid Dosage Forms Ointments and Creams

Control Tests

• Organoleptic evaluation

• Assay for active ingredients

• Test of rate of absorption

• Test for non-irritancy

• Test of rate of penetration

• Test of rate of drug release

• Test of rheological properties

• Test of content uniformity

• ID test for the active ingredients and possible contaminants

• Loss of water/water content

• pH + Sterility test

• Storage condition

• Stability test

• Minimum Fill

• Metal Particles in ophthalmic ointments

• Microbial Content

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QC chapter 2

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