STABILITY TEST PROTOCOL

1. PURPOSE :
To evaluate the stability of the Moment Biocell , in relation with the increase in the scale of
production of The Research and Development to Production Department

2. DESIGN TESTING
Samples stability test results production scale with batch numbers CEL60501 and
CEL 60502

2.1 Materials Testing :

Moment Biocell

Batch No Packaging Storage Conditions / Time

Long Term ( 2 years)
CEL 60501 Bottle
Accelerated ( 6 months )
CEL 60502 Long Term ( 2 years)
Bottle
Accelerated ( 6 months )

2.2 Test Plan:

2.2.1 Storage conditions and sampling interval

Bulk Moment Biocell packaged in bottles, then stored at storage conditions as
follows :

Storage Conditions Sampling Interval (months )

Long Term 0,3,6,9,12,18,24
30 ± 20 C/75 ± 5 % RH
0

Accelerated 0,3,6
40 ± 20 C/75 ± 5 % RH
0
2.2.2 Testing and Testing requirements
Research & Development Department is responsible for the storage of samples in
accordance with the conditions of storage, a sample was taken from a storage area
(Chlimatic Chamber) on the date of the examination schedule planned. The
execution of the analysis must be done no more than 3 days.

2.2.3 The parameters tested were as follows :

a. Organoleptic
 Appearance
 Taste & Odour

b. Testing Chemistry
 pH

c. Testing Heavy metal

 Lead ( Pb)
 Arsenic ( As)
 Mercury ( Hg )
 Cadmium ( Cd )

d. Testing Microbiological
 Total Aerobic Microbial Count
 Total Yeast & Mold Count
 Escherichia coli
 Salmonella
 Staphylococcus aureus
 Bile-Tolerant Gram-negative bacteria
3. TOTAL SAMPLE (batch / storage conditions)

3.1 Accelerated
Organoleptic : 2 Bottle
pH : 1 Bottle Amount of test : 3 time
Heavy Metal : 4 Bottle The required amount : 13 x 3 = 39 Bottle
Microbiological : 6 Bottle

3.2 Long Term

Organoleptic : 2 Bottle
pH : 1 Bottle Amount of test : 7 time
Heavy Metal : 4 Bottle The required amount : 13 x 7 = 91 Bottle
Microbiological : 6 Bottle

Prepared By Reviewed By

QC Executive QC/QA Assistant Manager