‘Stability Assessment
Finished Product Nam a
Heat Stability:
Put finished product in 50°C oven for 48 hours and restore to room temperature:
Observe whether there is oil and water separation.
Freeze and thaw Stability:
Put finished product in -18°C freezer for 24 hours. Restore to room temperature.
Repeat these 3 cycles and observe whether there are oll and water separation-
Centrifugal test:
Put finished product in centrifugal tubes and centrifuge at 4000 rpm for 20 minutes
and observe whether there are oil and water separation.
lity date of Finish« :
Stability Period:
PHYCICAL APPEARANCE: Cream
COLOR: yellow
opor: Characteristic
Stability | Starting [Month _| Month [Month [Month [Month | Month | Month. Month
period 0 3 6 9 2 15 18 21 24
Physical | Cream | Cream | Cream | Cream |Cream | Cream | Cream | Cream | Cream
appearance
Color Yellow | Yellow | Yellow | Yellow | Yellow | Yellow | Yellow | Yellow | Yellow
odor Charac- | Charac- | Charac- | Charac- | Charac- | Charac- | Charac- | Charac- | Charac-
teristic | teristic | teristic | teristic | teristic | teristic | teristic | teristic _| teristic
Testing is done with accelerated method by raising the temperature to 40°C for
month, During this period of 9 months with the simulated 40°C heat the product was
stable.
Rationale:
Samples had been stored at 40 C / 75% RH for 9 months. It was confirmed all the
results were within specification. As the confirmatory assessment, samples had
been stored at 25 C / 60 % RH for 3 years, with all favorable results within
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