STABILITY SUMMARY REPORT – DRAFT

Quality Control Department –

Product Name :
Generic name :
Batch No.: Batch Size :
Pack Size : Mfg. Date : Exp.Date :
Manufacturing site : Purpose of study :
Excipients use
Active use : DMF No.: API Batch No.:
API Manufacturing Site :
Description of container / closure system : Supplier :

White Opaque HDPE bottle :

Type of Desiccant : Not applicable Number of desiccant : Not Applicable
Storage condition : 25°С ± 2°С/60 ± 5% RH Stability protocol Reference No.: Version No.: 00
Sr.No: Test Specification Product Details :

Initial 3 Months 6 Months 9 Months 12 Months 18 Months 24 Months 36 Months 48 Months 60 Months
Sample removed from the chamber , Date Not Applicable
1. Description
2. identification by UV Spectroscopy
3. Average Weight
4. Loss on Drying (LOD ) at for 3 hrs. (%w/w)
5. Tablet Friability (%w/w)
6. Uniformity of dosage units (weight variation ) for 10 tablets
7. Microbial Limit Test
Total Aerobic Microbial Count (TAMC)
a. Total aerobic bacterial count
b. Total aerobic fungal count
c. Absence of pathogens salmonella spec.
d. Escherichia coli
e. Staphylococcus aureus
Date of Analysis :

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 Storage condition : 40°С ± 2°С/75 ± 5% RH Stability protocol Reference No.: Version No.: 00
Sr.No: Test Specification Product Details:

Initial 3 Months 6 Months 9 Months 12 Months

Sample removed from the chamber , Date Not Applicable
8. Description
9. identification by UV Spectroscopy
10. Average Weight
11. Loss on Drying (LOD ) at for 3 hrs. (%w/w)
12. Tablet Friability (%w/w)
13. Uniformity of dosage units (weight variation ) for 10 tablets
14. Microbial Limit Test
Total Aerobic Microbial count
f. Total aerobic bacterial count
g. Total aerobic fungal count
h. Absence of pathogens salmonella spec.
i. Escherichia coli
j. Staphylococcus aureus
Date of Analysis :

Conclusion: The product complies to the specification with respect to all the tests at the end 9th Months .

Prepared By :

Date :

Quality control :

Report completed Date :

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