| S.No. |
Ingredients |
Ratio |
Description |
FTIR |
| Initial |
55°C
(2 weeks) |
40 ± 2°C / 75 ± 5% RH (4 weeks) |
| 1 |
API |
1 |
Off white |
No change |
No change |
Complies |
| 2 |
Mannitol |
1 |
White |
No change |
No change |
Complies |
| 3 |
Kyron T-314 |
1 |
Off white |
No change |
No change |
Complies |
| 4 |
Glycine |
1 |
White |
No change |
No change |
Complies |
| 5 |
MCC PH 101 |
1 |
Off white |
No change |
No change |
Complies |
| 6 |
SLS |
1 |
White |
No change |
No change |
Complies |
| 7 |
Aerosil |
1 |
White |
No change |
No change |
Complies |
| 8 |
Magnesium stearate |
1 |
White |
No change |
No change |
Complies |
| 9 |
API+Kyron |
5:1 |
Off white |
No change |
No change |
Complies |
| 10 |
API+ MCC PH 101 |
1:5 |
Off white |
No change |
No change |
Complies |
| 11 |
API+Mannitol |
1:5 |
Off-white |
No change |
No change |
Complies |
| 12 |
API+ SLS |
10:1 |
Off white |
No change |
No change |
Complies |
| 13 |
API+Glycine |
4:1 |
Off white |
No change |
No change |
Complies |
| 14 |
API+ Aerosil |
5:1 |
Off white |
No change |
No change |
Complies |
| 15 |
API+ Mg. stearate |
5:1 |
Off white |
No change |
No change |
Complies |
|
