protocol stabilitas soocord
DESCRIPTION
Merupakan protokol dalam pembuatan tablet soocordTRANSCRIPT
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)
2.2 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”