Record the condition of product formula upon receipt and/or over time

Determine the integrity of the container closure system by dye intrusion technique. 2 containers required.

Confirm a chemical substance by method of a chemical in API.r

Determines the identity of an API powder / liquid using Ultraviolet and Visible wavelengths of light.

Determines the pH of an API or finished product.

Determines the density of a fluid, allowing for formulation conversions between weight and volume

Determines the concentration of active(s) in finished product. Determines the stability of a finished product at various time intervals.

Determines the concentration of active(s) in finished product. Determines the stability of a finished product at various time intervals.

Determines the concentration of active(s) in finished product. Determines the stability of a finished product at various time intervals.

Determines the concentration of active(s) in finished product. Determines the stability of a finished product at various time intervals.

Determines the concentration of active(s) in finished product. Determines the stability of a finished product at various time intervals.

Determines the concentration of active(s) in finished product. Determines the stability of a finished product at various time intervals.

Develops and validates Stability Indicating Assay (SIA) methods to establish BUD's, per <795> <797>

Using the SIA method developed in Phase 1 (SIA), study will establish the Beyond Use Date (BUD)

Tests for consistency of each dosage unit. Reported based on testing of 10 dosage units, per <905>.