LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Department Quality Control

Title Test Report Of Finished Product
Form No. Version Effective Date Page
QC/FORM/TR/FP/CZT001 02 01-01-2014 01 of 01

Prepared By Checked By Approved By

____________________ ____________________ ____________________
Asst. Manager, QC Asst. Manager, QC Deputy Manager, QA

PRODUCT NAME : CELOZIN TABLET PRODUCT CODE : CZT001

Generic Name & Strength : Cetirizine Dihydrochloride BP 10 mg Batch Number :
/ Tablet. Batch Size :
QC Reference No. : Pack Size :
Manufacturing Date : Expiry Date :

PARAMETERS SPECIFICATIONS RESULT REMARKS

Appearance : A Blue, round deep biconvex shaped film
coated tablet in 86 mm 34 mm Alu-PVC
blister pack.
Identification : Must comply with the identification test of
Cetirizine Dihydrochloride.
Loss on drying : Not more than 3.0%w/w.
Average weight : 124 mg 5 %.
Uniformity of weight : Not more than 2 of the individual
masses deviate from the average mass
by more than 7.5 % and none deviates
by more than 15 %.
Uniformity of Content : Complies with BP 2007 limit.
Diameter : 6.4 mm to 6.6 mm.
Thickness : 4.35 mm to 4.65 mm.
Hardness : Not less than 2.0 kg/cm2.
Leak Test : Must be leak proof at 400 mmHg in 4 min.
Disintegration Time : Not more than 30 minutes.
Dissolution : Not less than 80 % of the stated amount of
Cetirizine Dihydrochloride is dissolved in
45 minutes in water.
Assay : 95.0 % to 105.0 % of the label amount of
Cetirizine Dihydrochloride.

Comments: Tested on:

Test Performed By Test Checked By Test Approved By
____________________ ____________________ ____________________