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.
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.
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.
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 ____________________ ____________________ ____________________