Giss BLISS GVS PHARMA LTD. 11, Dewan Udyog Nagar, Ayal, Palghar, Maharashtra -401404, India ANALYTICAL METHOD VALIDATION REPORT FOR ASSAY OF BISACODYL IN BISACODYL SUPPOSITORIES BY LIQUID CHROMATOGRAPHY Page Nout of 17a BLISS GVS PHARMA LTD. 11, Dewan Udyog Nagar, Alyali, Palghar, Maharashtra ~401404, India, TTille ANALYTICAL METHOD VALIDATION REPORT FOR ASSAY OF BISACODYL IN BISACODYL SUPPOSITORIES Product [BISACODYL SUPPOSITORIES 10 MG. Report No__| RMV/30/00 Effective date [06.70.2074 ‘Supersedes | Ni Page No. Page 2 of 17 AUTHORISATION ‘This Report is valid only if endorsed and dated by a designated person of Bliss GVS Pharma Ltd. Deparinent | Raine | “basonaion | Sonate #0 . Prepared by | qualty Control Mr. ParkajPatl |r Execute | G2 9 Guay contol |e A 6 Me suntiamar | se Manager | (7 9 op bies meter lous cones |W Seminar serene | Fypai® 6 le srMansser 9 Approved by | quay Assurance |MEN | Baty ye Krone Oy& BLISS GVS PHARMA LTD. 11, Dewan Udyog Nagar, Alyal, Palghar, Maharashtra ~201404, India, “Tier ANALYTICAL METHOD VALIDATION REPORT FOR ASSAY OF BISACODYL IN BISACODYL SUPPOSITORIES Product [BISACODYL SUPPOSITORIES 10 MG ‘Report No. | RMV/30/00 Effective date [08 10.2074 ‘Supersedes | Ni Page No. Page 3 of 17 ‘TABLE OF CONTENTS Sr.No, Particulars Page Number 70 [Batch Detais a 20 | Ustof Standards 4 30 | Ustof reagents Z 40_[Ustof nsramenis & Equipments a 5O_| System sulabiy 3 60 | Specitcty 6 7.0 | System predsion 7 80 | Method Precision 8 ‘30 | intermediate Preckion 3-10 00 | Accuracy & Recovery T 710 | Uneariiy % 120 [Range 7% 730 | Solution siabiiy @ 740 | Filvaion study 7% 150 | Robustness 14-75 ¥60_ | Validation summery data 7 770 | Conctusion 7