Format for Stability Study of Tablet

Company Logo

Company Name Pvt. Ltd Address – Pakistan

S T A B I L I T Y    S T U D Y Brand name Tablet

Batch number :

Mfg. Date:

Initial study started on:

Type of study: Real time study

Storage conditions: 30 ± 2°C

Humidity:  65 ± 5%

Sr.#

Stability station

Initial

3rd month

6th month

9th month

12th month

Specification

1

Date of analysis

C H A R A C T E R S

2

Appearance

Complies

Complies

Complies

Complies

Complies

xyz color

3

Identification

+ve

+ve

+ve

+ve

+ve

+ve

4

Dispersion time

min

min

min

min

min

Not more then 5 min

5

Hardness

10.0 gm

10.00 gm

10.00 gm

10.00 gm

10.00 gm

10.00 gm + 2 %

6

Av. Wt.

+5

+5

+5

+5

+5

xyz(USP 2011)

7

Assay  Ingredients X Y z

101.0% 102.2% 100.8% 101.0%

101.0% 102.2% 100.8% 101.0%

101.0% 102.2% 100.8% 101.0%

101.0% 102.2% 100.8% 101.0%

101.0% 102.2% 100.8% 101.0%

90-110 % (USP 2011) 90-110 % (USP 2011) 90-110 % (USP 2011) 90-110 % (USP 2011)

Conclusion by: Results are found within limits/ pharmacopial specifications and no major changes are observed.

Study conducted by

Reviewed by

Approved by

Sig. Q.C. Analyst

Sig. Q.C Manager

Sig. Q.A Manager