BAFNA PHARMACEUTICALS LIMITED 147, MADHAVARAM REDHILLS HIGH ROAD, GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI - 52 QUALITY CONTROL DEPARTMENT -ERTIFICATE OF ANALYSIS “Montelukast sodium and Lavooetirzine dliydrvehlride tablets 10 ma Pagetot? | ‘Stell 1010/5 mg fl coated tablets FO211901 Pack modi 1ox10's | 18152007 ALR, Nos "TF 180300 | 60,000 Tablets Packing Batch size: 6,00,000 Tablets Nov. 2018 Exp. Date: Oe.2020 ‘Aualjsis Deter 22/12/2018, Report Date: 2s/2n018 | S.No. TESTS RESULTS LiMiTs 1. | Deseipton ‘White coloured, circular, biconvex | White coloured, cirelur, bcoavex fin coated tablets plain on bot sides, | film coated bles plain on both sides. Z| entiation (By HPLC) Retention time of Montelukast and/| Retention time of Monzivast ant 2) Monieukast, LLevocetrine Dihydrochlride peak | Levocetizine Dihydrochloride peak 1D) Levwoetsine Dibydrochlorde | iM test solution chromatogram | in tx solution chromatogram should Y vdrochloride | Cerexponds 10 the retention ime of | canespond to the retention tine of Monicukast and Levoceriave | Montciukat and Levocctizine Dihydrochloide peak in standatd | Dikydrochloride peak in standard solution chromatogram asin Assay. | solution chromatogram a in Asay ‘Average weight 65 ms. FTB.0 mg 22% (2724 mg, 192836 mg) _| | Whitormiy of weight None out of 20 wbiet deviate by | Not more than 2 ublew oat oF 20 tet toore thin + 5 4 of the average | tablets hive deviation over # 5 % of weight the average weight an node of the Range =~ 125104 1.6% tablets must have deviation more than - 10 % of the average weight 5. | Disintegration ‘Oi wineee 8 TT econ ‘Not more than 30 mines in water a arce7c & | Dissolution (By HPLC) i 4 2) Montelukast Average = 96.9% Not less thun 85.0 8 (80.0% (Q) + Range =960 % 10985 % 5 %) of the labeled amount of active dissolved in 30 minutes. 1b) Levocetrisine Dinydrochlride | Ayerage= 1014S Not les hun 850% nee 71 10 (80.0 % (Q) + 5.) of the labeled pa eit amount of active dissolved in 45 minutes 7 | Uniformly of dosage units By 7 HPLC) 2) Montelukast hanpiaes ansa23 Acceptance value should nt be more ned than 15.0 for 10 nis) | 1) Levecetrizine Dinydrochloride | Acceptance vale = 12.3 ‘Acceptance value should not be more than 15.0 or 10 uit) eee g Checkea By Approved By Signature: Signature: tv At Signature: Date ews Date: MAY ce Ne Dae Peaks Name: MNN.Bangarayys Name NRRavichandean Name: Seerivasale’G Designation; Dy. Manager @C_—-Designation: AGM - QC Designation: AGM. QABAFNA PHARMACEUTICALS LIMITED 147, MADHAVARAM REDHILLS HIGH ROAD, GED GRANTLYON VILLAGE, VADAKARAI POST, CHENNAI - 52. — QUALITY CONTROL DEPARTMENT CERTIFICATE OF ANALYSIS Generic name: Montelukast sodium and Levocetelne diy drochloride tablets 105 mg "Page 2 of 2 Brand name: Stel LOmp/S mg film coated tablets i Product code: FU211901 Pack mode: 10X10% Batch No 18152007 ALR. Nos “TF 180300 Batch si 6,00,000 Tablets Packing Butch size: 6,00,000 Tublets [ Mf Date: Nov. 2018 Exp. Date: Oct. 2020 ‘Analysis Date: 22/12/2018, Report Date: 25/1272018 SNe TESTS RESULTS LIMES 8. | Related Substances (By HPLC) re 3 1) Montelukast impurities Any impurity 0.006 % [Not move than 0.5 % '. Total impurities 0.006 % Not more than 1.0 % 11) Levocetvizine impurities Any impurity 0.02% [Not more than 0.5% b. Total impuies 0.02% Not more than 1.0 % 1M) Total impacitis (impurities of | 0.03 % Not more than 2.0 % Montelukast + Impurities of fe Levocetirizine Hydrochloride) 5, [Assay By HPLO) = Each film-coated tablet contains: 8) Montelukast sodiam equivalent | 10.10 mg. 9.50 mg to 10:0 mg to Montelukast 10 mg (101.0 6 of abel clan) (95.0 % to 105.0% of label cain ») Levocetivizine Dihydrochtoride | 4.87 mg. 4.35 mg 105.25 mg. Smg (574 of label claim) (95.0 to 105.0 of label ctsim) To. | Microbial Limits ™ ‘Not applicable : 7 i) Total Viable Aerobic Count 8) Total Aerobie Microbiel [Not more than 1000 CFUe Count ) Tota! Yeast and Mould [Not moe than 100 CFU /p Coune ii) Escherichia Coli Should be absenvg ‘Note: Tet naked ¥, not routinely cared ou, perfor Yor Fn 3 batches thereafter pevTorn for not less tan one Ta every TO" batch or first batch af the year whichever sei. ‘Remarks: The sample complies as per In-house release Specification No.: FPS: FO219 Revision OL Prepared By Checked By Approved By Signature: 4 ra Signature: fr 3 Signature: Dat: A MAL alee Bes Sach are Name: MNVBangunya Name NARRivichondran Name becsivasing Designation: Dy. Manager QC Designation: AGM-QC Designation; “AGM -Qa