Protocol Stabilitas Soocord

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 30°C / 75% RH

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

Accelerated 40°C / 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 Studycontent & 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

12. Test result in tabular form

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 StabilityThe physical stability of SocoCord tablets 5 mg, 10 mg, and 20 mg proved to be unchanged after storage up to 36 months at 30°C/75% RH and 40°C/75% RH

Chemical Stability

a. Stability under Real time Conditions

Storage for up to 36 months at 30°C/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 30°C”