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1-Test Report of Celozin Tablet Ok

This test report summarizes quality control testing of Celozin tablets, a generic cetirizine dihydrochloride 10 mg tablet. Parameters tested included appearance, identification, loss on drying, average weight, uniformity of weight, uniformity of content, diameter, thickness, hardness, leak test, disintegration time, dissolution, and assay. Results for each parameter were reported to ensure specifications were met. The report provides quality control documentation for a specific batch of the finished pharmaceutical product.

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244 views1 page

1-Test Report of Celozin Tablet Ok

This test report summarizes quality control testing of Celozin tablets, a generic cetirizine dihydrochloride 10 mg tablet. Parameters tested included appearance, identification, loss on drying, average weight, uniformity of weight, uniformity of content, diameter, thickness, hardness, leak test, disintegration time, dissolution, and assay. Results for each parameter were reported to ensure specifications were met. The report provides quality control documentation for a specific batch of the finished pharmaceutical product.

Uploaded by

ShagorShagor
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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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
____________________ ____________________ ____________________

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