SHROOQ PHARMACEUTICAL (PVT)LTD

QUALITY ASSURANCE DEPARTMENT

FRIABILITY TEST
SOP NO. DATE NEXT REVIEW DATE REVISION PAGES
QAD-SOP-018 April 05, 2017 April 05, 2019 1 2

PREPARED BY REVIEWED BY APPROVED BY AUTHORIZED BY

MISS SIDRA NOREEN RANA ANWAR AHMED SHEHZAD AHMAD KHAN QAMAR JAVAID
QUALITY ASSURANCE QUALITY CONTROL QUALITY ASSURANCE PLANT MANAGER
OFFICER MANAGER MANAGER

1 Purpose
This test is performed for determination of Quantitative measurement of wear tear of tablets.

2 Scope
Applicable to the uncoated tablet dosage form.

3 Responsibilities
 IPQC Officer
 Production Officer

4 Accountability
HOD-Quality Assurance

5 Procedure
 Remove the drum from the Tablet Friability Apparatus and clean / de-dust with dry
duster.
 For Tablets weighing up to 650mg each, use a 6 -- 6.5gm sample. A minimum
number of 20 tablets should be used in test. For Tablets weighing over 650mg each,
a 10 tablets sample is sufficient.

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 SHROOQ PHARMACEUTICAL (PVT)LTD

 For tablets with a unit mass equal to or less than 650mg, take a sample of whole
tablets corresponding as near as possible to 6.5gm. For tablets with a unit mass of
more than 650mg, take a sample of 10 whole tablets.
 Attach it with apparatus by tightening locking screw.
 Operate for 4 minutes to meet 100 revolutions.
 After operation remove the dust the tablets and weigh.
 Using the following formula calculate the weight loss.

A-B
Friability = ________ x 100 = %
A
Where
A = Weight of tablets before operation.
B = Weight of tablets after operation.
% = Percentage loss.

 The Friability must not be more than 1%.
 If result is unsatisfactory or tablets are broken down repeat the procedure twice and
calculate the mean result obtained from three consecutive operations.

6 Records:
Batch Processing & Control Record

7 List of recipients
 IPQC In-Charge
 Quality Assurance Officer
 Quality Assurance Manager

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