STABILITY STUDY PROTOCOL TEMPLATE (FOR ASPIRIN TABLETS 75mg)
| Prepared By | Checked By | Approved By |
|
|
||
| Designation: | Designation: | Designation: |
| Date: | Date: | Date: |
| Sr. No. | Content | Page No. |
| 1 | Objective of study | |
| 2 | Responsibilities | |
| 3 | Product details | |
| 4 | Packaging and batch details | |
| 5 | Test parameters and specification | |
| 6 | Testing schedule | |
| 7 | Storage condition and stability duration | |
| 8 | Sample quantity | |
| 9 | Significant change criteria | |
| 10 | Test procedure and criteria | |
| 11 | Report generation |
- Objective of study
This protocol is prepared to carry out stability study of process validation and ongoing batches of Aspirin 75 mg Tablets, batch size 100000 Tablets as per ICH guideline. Each Aspirin Tablet contains 75 mg of Aspirin BP.
- Responsibilities:
Quality control:
– Prepare of stability protocol
– Withdraw samples from chambers as per stability study schedule
– Carry out test according to test procedure
– Prepare stability report
Quality assurance:
– Sampling of stability samples
– Approve the stability study protocol
– Approve the stability study report
- Product details
| Product description | |
| Product licence No. | |
| Shelf-life |
- Packaging and batch details
| Packaging style | |
| Primary packaging material | |
| Number of batches for stability study | |
| Batch number | |
| Reason for stability | |
| Stability condition | |
| Mfg. Date | |
| Exp. Date |
- Test parameters and specification
| Sr. No. | Test parameters | Limit |
| 1 | Description | |
| 2 | Identification | |
| 3 | Average weight | |
| 4 | Uniformity of weight | |
| 5 | Diameter | |
| 6 | Hardness | |
| 7 | Disintegration | |
| 8 | Friability | |
| 9 | Moisture content | |
| 10 | Free salicylic acid | |
| 11 | Assay | |
| 12 | Microbial limit test | |
| 13 | Pathogens |
- Testing schedule:
| Time points (Months) | |||||||||
| Test | Specification | 0 | 3 | 6 | 9 | 12 | 18 | 24 | 36 |
| Conditions to be tested at time point | 250C/60% | 250C/60% | 250C/60% | 250C/60% | 250C/60% | 250C/60% | 250C/60% | 250C/60% | |
| Description | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Identification | ✓ | X | X | X | X | X | X | X | |
| Average weight | ✓ | X | X | X | X | X | X | X | |
| Uniformity of weight | ✓ | X | X | X | X | X | X | X | |
| Diameter | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Hardness | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Disintegration | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Friability | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Moisture content | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Free salicylic acid | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Assay | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Microbial limit test | ✓ | X | X | X | ✓ | X | ✓ | ✓ | |
| Pathogens | ✓ | X | X | X | ✓ | X | ✓ | ✓ | |
✓- To be tested
X- Testing not required
| Time points (Months) | ||||||
| Test | Specification | 0 | 3 | 6 | 9 | 12 |
| Conditions to be tested at time point | 300C/65% | 300C/65% | 300C/65% | 300C/65% | 300C/65% | |
| Description | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Identification | ✓ | X | X | X | X | |
| Average weight | ✓ | X | X | X | X | |
| Uniformity of weight | ✓ | X | X | X | X | |
| Diameter | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Hardness | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Disintegration | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Friability | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Moisture content | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Free salicylic acid | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Assay | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Microbial limit test | ✓ | X | X | X | ✓ | |
| Pathogens | ✓ | X | X | X | ✓ | |
✓- To be tested
X- Testing not required
| Time points (Months) | ||||
| Test | Specification | 0 | 3 | 6 |
| Conditions to be tested at time point | 400C/75% | 400C/75% | 400C/75% | |
| Description | ✓ | ✓ | ✓ | |
| Identification | ✓ | X | X | |
| Average weight | ✓ | X | X | |
| Uniformity of weight | ✓ | X | X | |
| Diameter | ✓ | ✓ | ✓ | |
| Hardness | ✓ | ✓ | ✓ | |
| Disintegration | ✓ | ✓ | ✓ | |
| Friability | ✓ | ✓ | ✓ | |
| Moisture content | ✓ | ✓ | ✓ | |
| Free salicylic acid | ✓ | ✓ | ✓ | |
| Assay | ✓ | ✓ | ✓ | |
| Microbial limit test | ✓ | X | ✓ | |
| Pathogens | ✓ | X | ✓ | |
✓- To be tested
X- Testing not required
- Storage condition and stability duration
| Study type | Condition | Duration |
| Accelerated | 40oC + 2oC/60% + 5% RH | 0,3,6M |
| Intermediate | 30oC + 2oC/65 + 5% RH | 0,3,6,9,12M |
| Long term | 25oC + 2oC/60% + 5% RH | 0,3,6,9,12,18,24,36M |
- Sample quantity
| Test parameter | Sample quantities (Tablets) |
| Description | |
| Identification | |
| Average weight | |
| Uniformity of weight | |
| Diameter | |
| Hardness | |
| Disintegration | |
| Friability | |
| Moisture content | |
| Free salicylic acid | |
| Assay | |
| Microbial limit test | |
| Total samples required for study |
Blister calculation:
| Storage condition | Frequency (Month) | Number of blister/Frequency | Required blister per storage condition |
| Accelerated | 0,3,6M | ||
| Intermediate | 0,3,6,9,12M | ||
| Long term | 0,3,6,9,12,18,24,36M | ||
| Total blisters for study | |||
- Significant change criteria
– A 5% potency changes from the initial assay value of batches.
– Any degradation product exceeding to its acceptance criteria
– Failure to meet the acceptance criteria for dissolution for 12 dosage units
– Failure to meet acceptance criteria for appearance, physical and microbiological parameters.
- Test procedure and criteria
All test shall be performed as per standard testing procedure reference number ST/TP/01.
- Report Generation
Test result of each frequency shall be reported and approved. Any OOS or OOT
shall be handled as per SOP. After completion of study, final compiled report
shall be prepared.
Copyright Notice: This Article/SOP/Compilation/Published Content is protected by Indian & International Copyright Laws. Reproduction and Distribution of the same without written permission is prohibited. Mail us at: info@pharmastate.com
For any Feedback or suggestion mail at: info@pharmastate.com
Weblink – https://pharmastate.com/
Applink- https://goo.gl/mS8Lr7
Great Post ! Thanks for the information about quality control