2B i ae cere en nc AX sarti Drugs Limited ZEROES Se je Aarti Drugs LImited pe amenrtnmysn Wom woman vance snge cnn on Se re Paige, Ber Trane =40" S06 (4) INDIA Tel. 01-2525 2702807271680 Pax 91 2528 273908 QUALITY CONTROL CERTIFICATE OF ANALYSIS Product : CELECOXIB USP Batch Size Batch Number : CEBM10020035 CAS Number Manufacturing Date: FEB. 2020 A.R.No. Expiry Date JAN, 2025 Analysis Date [Bate TESTS TMT 7 | Appearance Awhie or most white, cystaline powder 2 | Solubility Soluble to Fealy soluble in ethanol Soluble in methylene chloride, practically insoluble in water 3 [entiation A)LR. The IR spectrum of sample concordant with Sop working spectrum of Celecoxib, By APLC “The retention ime of the major peak of the rc ‘sample solution corresponds to that of the standard solution , as obtained in assay. | Related substances | Celecoxib related compound A D.005% by HPLC Not more than 0.4 %. | ‘Celecoxib related compound B 005% = Not more than 0.10 %. Tnaividval unspecified impurity DOT = Not more than 0.10 %. "Total impurity = Not more than 0.5 % DOa% [Water content Not more than 0.5 %, 0.03% [Residue on Ignition | Not more than 0.2% 0.05% 7 [Assay by HPLC Not less than 98.0% and Not more than 102.0% on anhydrous basis 98.37% ‘Additional test as per party's requirement_ #8 [Residual solvents | Methanol - Not more than 3000 ppm 754,66 ppm “Toluene = Not more than 880 ppm. Not detected Benzene Not more than 1 ppm Not detected 7 _[Paricle size 1D90_Less than 30 micron Complies OPINION __: The above material is Complies as per USP specification [Prepared By [CES Checked By [3 Approved By [7 Ge Oficer | Monika Serode | Oc Executve | Sanjay J. Shinde [GC Head | MadhukarC. Kole zi (03/03/2020 Date (03/03/2020 Date 30372020 | Factory Address + Plot No, W-60(B), 61 (8), 62 (8), 71 (B), 72 (8), 73 (), ML Tal. eee ie es at ithe oxsns-27@438, Fax 0252