Automated System for Kinetic Analysis of Particle Size Distributions for Pharmaceutically Relevant Systems

Table 3

Calcium phosphate solubility in an admixture—conditions for effect of pH.

Parameter	Setting
Test article	5% amino acid/15% dextrose with electrolytes
Container	1-liter glass bottle
Temperature (°C)	37
Targeted pH	4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, and 8.0
Threshold particle size (𝜇m)	≥1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 15.0, 25.0, and 50.0
Calcium (mmol/L)	0.232 mmol/mL [Ca^2+] added at 1.5 mL/hour to 12 mmol/L
Phosphates (mmol/L)	24
Interval testing	Periodically for approximately 35 hours, approximately every 20 minutes