Unicure Remedies Pvt. Ltd ANALYTICAL METHOD VALIDATION PROTOCOL FOR DISSOLUTION Produet Name Tevonorgestiel Tablets BP 15mg Tabel Gaim Tach fimeoated tablet contains, Levonorgestrel 8P 15mg Speteation W708 Nathod By HPLC Teason fr validation Regulatory Requirement Tel Speciation nd OA No | FPWUTI2 and FPS Document No TRPUTANVIDT O02 Fein No: o Reason for reison Wot pple erate OT Adee 2048 Total No. of pages 5 inclusive ofthe tite pageUnicure [Analjieal Method Validation Protocol fr Dissolution of Levonorgestrel Tablets BP |.5mg Doz No: URPLIAMVIDI 0020 Approvals Time Designation [Signature bite Prepared By. Mr. Himanshu Dave Sr. Officer QC Reviewed By | Mrs Manisha Path | St Manager QC os PANT doy? Poproved by | Ms.jayaPatel | Dy Manager aa Closes TINCONTROLLED COPY FOR REGISTRATION ONLY QO maeunicure ‘Analfeal Method Validation Protocol or Doc. No: URPLIANVIDIFV60z0 Dissolution of Levonorgestrel Tablets BP 15mg enn Contents Na Site Page No. 10 | introduction 5 20 | Objective 5 30 | Scope 5 40 | References 3 5.0 | Responsibities 3 60 | Designofsudy 6 ‘Chena, Column, Sample, Pacebo , Working 10 7 Standard and Instruments required ‘80 | Analytical Method @ Valiation Progam 9 9.1 Recurey 9 90 92 Precision Ww 9.2.1 System Precision 1 9.2.2 Repeatability (Method Precision) 2 UNCONT! TED COPY FOR REGISTRATION OWLY Sign. / Date Se