te -oven-areat ese 200 Ippea Laboratories Limited Sfipca TELEFAX 072-2, 75083, 0. SEIAVTA 45702, DIST. RATLAM (MP) QUALITY DIVISION CERTIFICATE OF ANALYSIS NAME OF THE PRODUCT : CILOSTAZOL USP (MICRONISED) BATCH SIZE : 439.0Kgs BATCH No. : 5004CB2AJI MFG. DATE : Sep. 2014 A.R.No, —: IBD-158826 EXP.DATE : Aug. 2019 DATE 2 04/02/2016 TESTS SPECIFICATIONS RESULTS DESCRIPTION White to off-white crystals. White crystals Freely soluble in chloroform; slightly soluble in methanol | Conforms | and in alcohol; practically insoluble in water. IDENTIFICATION ‘A. The infrared absorption spectrum of sample and | Conforms standard are concordant. B. The retention time of the major peak in the Conforms chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. LOSS ON DRYING NMT 0.3% wiw 0.15% wiw (at 110°C for 3 hours) RESIDUE ON IGNITION | NMT 0.1% wiw 0.07% whw CHLORIDE NMT 0.018% wiw < 0.018% wiw HEAVY METALS NMT 0.001% wiw < 0.001% wiw RELATED Cilostazole Related CompoundA =: NMT.0.10% — | < 0.05% COMPOUNDS Cilostazole Related Compound B NMT 0.10% < 0.05% (By HPLC) Cilostazol Related Compound C :NMT 0.10% | < 0.05% Any other Individual Impurity :NMT 0.10% — | < 0.05% Total Impurities NMT 0.40% — | < 0.05% RESIDUAL SOLVENTS | Methanol NMT 3000 ppm BDL Isopropyl alcohol NMT 5000 ppm < 450 ppm ASSAY (By HPLC) 98.0% - 102.0% of CzcHz1NsOz (on dried basis) 99.7% (odb) REMARKS: The above sample CONFORMS as per USP Specifications. Note : BDL- Below Detection Limit Re PREPARED BY MANAGER QUALITY CONTROL DATE : 13/07/2016 DATE OF PRINT : 13/07/2016 Regd Of 48, Kandi nual Etat, Kani (Wes), Nurba-0087. Phone: @B47 4A Corporate fice: 14248, Kan Industral Ett, Kan (Wes), Munba-40 067. Phone: 8474747TEL :07412~27eae,272so, 278000 TELEFAX: 07612-77864, 270085, Ipca Laboratories Limited P.O, SEIAVTA 457 002. DIST, RATLAM (MP) S£ipca QUALITY DIVISION CERTIFICATE OF ANALYSIS NAME OF THE PRODUCT : CILOSTAZOL USP (MICRONISED) BATCH SIZE : 407.0 Kgs BATCH No. : 5002CB2AJI MFG. DATE : Sep. 2014 A.R.No. —: IBD- 151020 EXP. DATE : Aug. 2019 DATE 1 19/11/2015 TESTS SPECIFICATIONS RESULTS DESCRIPTION White to off-white crystals. White crystals Freely soluble in chloroform; slightly soluble in methanol | Conforms and in alcohol; practically insoluble in water. IDENTIFICATION A. The infrared absorption spectrum of sample and Conforms ‘standard are concordant. B. The retention time of the major peak in the Conforms: chromatogram of the Assay preparation corresponds to that in the chromatogram of the ‘Standard preparation, as obtained in the Assay. | LOSS ON DRYING NMT 0.3% wiw 0.16% wiw (at 110°C for 3 hours) RESIDUE ON IGNITION | NMT 0.1% wiw 0.05% wiw CHLORIDE NMT 0.018% wiw < 0.018% wiw HEAVY METALS NMT 0.001% wiw < 0.001% wiw | RELATED Cilostazole Related Compound A = NMT 0.10% Not Detected COMPOUNDS Cilostazole Related Compound B NMT 0.10% < 0.05% (By HPLC) Cilostazole Related Compound C NMT 0.10% < 0.05% Any other Individual Impurity NMT 0.10% | < 0.05% Total Impurities = NMT 0.40% < 0.05% RESIDUAL SOLVENTS | Methanol = NMT 3000 ppm Not Detected Isopropyl alcohol : NMT 5000 ppm < 450 ppm. ASSAY (By HPLC) 98.0% - 102.0% of CagH27N;O, (on dried basis) 99.7% (odb) REMARKS : The above sample CONFORMS as per USP Specifications. ay f ye PREPARED BY DATE : 13/07/2016 Y/ es QUALITY CONTROL DATE OF PRINT : 13/07/2016 ga. OF: 4, Kandi ndstial Estat, Kandi (Wes), Mumbai 400 O67. Phone: 66474444 Corprate ice 14248, Kan nds Ett, Kani (Wes), Mumbal-400 057. Phone 6547 4747Te. :oree-zrats.zres9.2700 — Tpca Laboratories Limited Sfipca TELEFAX: 0412708, 27069 PO. SEJAVTA 457002, DIST. RATLAM (MP. QUALITY DIVISION CERTIFICATE OF ANALYSIS NAME OF THE PRODUCT: CILOSTAZOL USP (MICRONISED) BATCH SIZE : 422.20 Kgs BATCH No. : 5003CB2AJI MFG.DATE =: Sep. 2014 A.R.No. — : IBD -152828 EXP.DATE _: Aug. 2019 DATE 2 19/06/2015 TESTS ‘SPECIFICATIONS RESULTS DESCRIPTION White to off-white crystals. White powder Freely soluble in chloroform; slightly soluble in Conforms methanol and in alcohol; practically insoluble in water. IDENTIFICATION A. The infrared absorption spectrum of sample and | Conforms standard are concordant. B. The retention time of the major peak in the Conforms chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. LOSS ON DRYING NMT 0.3% wiw 0.19% wiw (at 110°C for 3 hours) RESIDUE ON IGNITION | NMT 0.1% wiw 0.04% wiw CHLORIDE NMT 0.018% wiw < 0.018% wiv HEAVY METALS NMT 0.001% wiw | < 0.001% wiw RELATED Cilostazole Related Compound A =: NMT.0.10% | < 0.05% COMPOUNDS Cilostazole Related CompoundB_ =: NMT0.10% | < 0.05% (By HPLC) Cilostazole Related Compound C NMT 0.10% | < 0.05% Any other Individual Impurity NMT 0.10% | 0.05% Total Impurities = NMT 0.40% | 0.05% RESIDUAL SOLVENTS | Methanol NMT 3000 ppm Not Detected Isopropyl alcohol NMT 5000 ppm < 450 ASSAY (By HPLC) 98.0% - 102.0% of CarHarNsOz (on dried basis) _| 99.5% (odb) REMARKS: The above sample CONFORMS as per USP Specifications. Q MA PREPARED BY MANAGER QUALITY CONTROL DATE : 13/07/2016 DATE OF PRINT : 13/07/2016 Regd. O48, Kandi nda Estate and (West, Murai 400067. Phone: 6647 aaa Compre Ofice 1428, Kandi nds Etat, Kani (Wes), Murbal-400 087. Phone : 6547 4747