SOP

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  
  1. 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.

  1. 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

  1. Product details
Product description  
Product licence No.  
Shelf-life  
  1. 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  
  1. 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  
  1. 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

  1. 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
  1. 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  
  1. 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.

  1. Test procedure and criteria

All test shall be performed as per standard testing procedure reference number ST/TP/01.

  1. 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.

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