Evaluation of Ophthalmic Preparations

Physical Evaluation:

1. Appearance: Check for clarity, color, and absence of particulates.

2. Viscosity: Measure viscosity to ensure optimal retention on the eye.

3. pH: Verify the pH matches tear pH (6.5–7.5).

4. Osmolality: Confirm isotonicity with tear fluid.

Chemical Evaluation:

1. Assay: Determine the drug content and ensure uniformity.

2. Stability Testing: Evaluate degradation over time under various conditions.

Microbiological Evaluation of Ophthalmic Preparations:

1. Sterility Test: Confirm sterility using membrane filtration or direct inoculation.

2. Preservative Efficacy Test: Assess the effectiveness of antimicrobial preservatives in multi-dose containers.

In Vitro and In Vivo Tests:

1. In Vitro Release: Measure drug release rate from ointments or gels.

2. Ocular Irritation Test: Evaluate irritation potential using animal models (if ethically permissible) or alternative methods.