Table 1.
Relative standard deviation calculated from content uniformity data over 4 months completed by HPLC analysis for three iDPC formulations containing 10%, 45%, and 80% L-glutamic acid.
| Formulation | Month 0 (%RSD) (%) | Month 1 (%RSD) (%) | Month 2 (%RSD) (%) | Month 4 (%RSD) (%) |
|---|---|---|---|---|
| iDPC 10% | 0 | 1 | 0 | 0 |
| iDPC 45% | 1 | 2 | 1 | 2 |
| iDPC 80% | 4 | 1 | 2 | 2 |
The process parameters of the iDPC formulations are as follows: 2.5 min of pre-processing time, 17.5 min of process time, 22.5 l/min flow rate, 95 relative centrifugal force (RCF).