General Test Procedure Determination Uniformity Of Weight Of Tablets

 

General Test Procedure Determination Uniformity Of Weight Of Tablets

 

1. Purpose

   1. This procedure is applicable to all In-process and Finished product.

2. Apparatus

   1. Analytical Balance

3. Reagents

   1. Nil

4. Procedure

   1. Method: Weigh individually twenty units taken at random and determine the average weight (mass). Not more than two of the individual weights (mass) deviate from the average weight (mass) by more than the percentage deviation shown below and none deviated by more than twice that percentage.

Pharmaceutical form	Average weight	% deviation
Tablets (Uncoated and Film coated )	Less than 80 mg	10
	More than 80 and less than 250 mg	7.5
	More than 250mg	5

1. 2. Calculate the percentage deviation for highest individual weight tablet as follows:

                               — Highest individual weight of tablet in mg – Average weight of tablets in mg

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––X100

–Average weight of tablets in mg

1. 3. Calculate the percentage deviation for lowest individual weight tablet as follows:

                                                                         —-Lowest individual weight of tablet in mg – Average weight of tablets in mg

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––X100

—Average weight of tablets in mg

5. Reference

   1. None

6. Revision History

Revision No.	Details of Changes	Reason for change
00	New GTP	NA

End of Document