Protocol of Stability

Study SooCord Tablets

SooCord Tablets 5 mg,

10 mg and 20 mg
Packed in Alufoil 10
tablets/strip
1. Purpose

Bertujuan untuk menguji stabilitas produk

setelah dilakukan scale up dari skala research
development ke skala produksi.

2 Test Design
Produk di kemas dalam alufoil strip dan
disimpan sesuai dengan penyimpanan yang
disesuaikan dalam instruksi produksi
(manufacturing)

2.1 Test Material

2.2 Testing Plan

a. Kondisi penyimpnana dan interval
sampling
Tablet Soocord dikemas dalam Alufoil
strip, dengan jumlah 10 tablet/strip, pada
kondisi penyimpanan :
Storage Condition

Sampling Intervals

Long term 30C / 75%

RH

0, 3, 6, 9, 12, 24, 36
bulan

Accelerated 40C / 75%

RH

0, 3, 6 bulan

b. Testing and Test Criteria

Departeman QA/QC bertanggung jawab
untuk penyimpanan dan pengujian sampel
berdasarkan pada kondisi penyimpanan dan
metode yang valid.
Sampel diambil dari penyimpanan
sebelumnya, untuk parameter yang diuji:
a. Physical test: Meliputi kadar dan kekerasan
setahun 3 kali selama 3 tahun.
b. Content : SooCord
c. Degradation Product : -

C. Number of Samples
3.1. Accelerated Test
content & impurity : 10 tablets
hardness
: 10 tablets

Total

: 20 tablet

Frekuensi pengujian : 2 kali

= 2 x 20 tablet
= 40 tablet
= 4 strip @ 10 tablet

Long term Stability Study

content & impurity : 10 tablets
hardness
: 10 tablets

Total

: 20 tablet

Number of tasting

: 6 kali

= 6 x 20 tablet
= 120 tablet
= 12 strip @ 10 tablet
Total untuk long term & accelareted 16 strip

. Report Content :
1. Responsibility
2. Summary
3. Objective
4. Test Material
5. Composition
6. Packaging
7. Storage condition and testing materials (Schedule)
8. Analytical Procedures
9. Reference Standard
10. Results
10.1. Physical Stability
10.2. Chemical Stability
10.2.1. Stability under real time storage condition
10.2.2. Stability under accelerated storage condition
11. Discussion/Conclusion

ANALYTICAL PROCEDURES
The stability tests on Paracetamol were
performed according to the control tests of
USP.
In the course of the stability testing the
main emphasis was put on the stability
relevant test items as listed below:

RESULTS
Physical Stability
The physical stability of SocoCord tablets 5 mg, 10
mg, and 20 mg proved to be unchanged after storage
up to 36 months at 30C/75% RH and 40C/75% RH
Chemical Stability
a. Stability under Real time Conditions
Storage for up to 36 months at 30C/75% RH had
no significant effect on the chemical stability of the
drug product.
b. Stability under Accelerated Conditions
Storage under accelerated conditions for 6 months
did not effect the chemical stability. The content of
SooCord was not significantly changed compared
to the initial value of the batches.

Conclusions
Storage under real time testing conditions causes
insignificant change of assay results of SooCord.
Significant changes in physical and chemical stabilities
were not observed. Since the long-term data and
accelerated data show little or no change over time
and little variability, a statistical analysis is considered
unneecessary.
Shelf-life:

Based on the result data the shelf-life has been

established for five years.
Storage Directions:

The product can be labelled with Store below 30C