ep TAGOOR LABORATORIES PVT. LIMITED (UNIT-I) Factory: Survey.:29, Tupakulagudem village, Pochavaram panchayat, Tallapudi mandal, West Godavari District, Andhra Pradesh -534341 , INDIA. E-mail :sales@itagoorchemicals.com, www:tagoorlaboratories.com Certificate of Analysis ‘Name of the Product HYDROXYCHLOROQUINE SULPHATE, IP Batch No. HCQ-0060221 ‘[Date of Analysis 22027021 Batch Quantity 300.0 kes ‘Analysis Completed On_| : | 23/02/2021 ‘Analytical Report No. |= | AR/FP/HCQ/00060221_| Mfg. Date = [ Feb™2021 Re-Test Date Fan"-2026 SNo. TEST Specifications Results 1.0. | Description ‘A White or almost white erystalline powder. Some ITE | Freely soluble in water, Practically insoluble 20: [Solotily in Ethanol (96%) and in methylene Chloride _| CO™PleS Identification ‘The IR absorption spectrum of the preparation of the test sample is concordant with same that 3.0. | A)IR of a similar preparation of the | Complies hydroxychloroquine sulphate (working standard). By Test For Sulphate | A white precipitate is formed Complies EO_| pH .0% wiv Solution) | Between 3.5 to 5.5 51 ‘A 10 per cent w/v solution is not more 5.0. | Appearance of solution | than slightly turbid and not more than slightly | Complies yellow Related substances By HPLC 2-[4-[(7-chloro-1- quinolinyl)amino}pentyl] | Not more than 0.5% 03% 6.0. | amino ethanol “Any Other Individual | 5+ more than 0.5% a Impurity Total Impurity Not more than 1.0% 0.7% 70_| Chlorides ‘Not more than 350 ppm . Less than 350 ppm 8.0_| Lead ‘Not more than 20 ppm Less than 20pm 9.0 _| Sulphate Ash (% w/w) Not more than 0.2%w/w_ _ 0.05%w/w_ 10.0 | Loss on Drying ‘Not more than 2.0%w/w [0.2% w/w Assay by gh CHIR A ely, Not ess than 98.0%ww and Not morethan | gy gee | 100.5%w/w 5 | (on Dried Basis) Ssprmasiant Remarks «| The material Compifes “does not complies to the above sgpficaians )=4) _ Storage Condition |: [| Store protected from light. WN ZS) Condi » ; ‘Compiled by Checked by: | Authorized Signatory *g pet iD Teal eee eee (ate os] | Date ral Date 1Blesiras_| Pee 13 |o5] 2024 : Page tof