_ Atul Bioscience Ltd Plot N-37, Additional Ambernath Industrial Ares, MIDC, Anand Nagar MMR Zone-lI, Ambernath (East) 421 506, Maharashtra, India pharma@atul.co.in | wwwatuibio.co.in CERTIFICATE OF ANALYSIS VALACYCLOVIR HYDROCHLORIDE USP Page 1/3 BATCH NO. : FG0S92100001 DATE OF MFG. : APR-2021 BATCH SIZE 191 KG RETEST DATE : MAR-2024 ANALYTICAL REPORT NO. : MUI/2122/QCP/FGQ/00028 DATE OF ANALYSIS —: 10/05/21 CONSIGNEE : MEMPHIS PRODUCTS S.A. DISPATCH QUANTITY : 50KG SR. TEST | SPECIFICATION RESULT NO. 1 _| Appearance White to off white powder ‘White powder 2 | Identification ‘A)IR absorption spectrum of test sample ‘Complies Test A)IR should concordant with IR absorption spectrum of working standard. Test B) HPLC B) The retention time of major peak of sample ‘Complies | solution corresponds to that of the Standard - solution, as obtained'in the Assay 3 | Chloride test It gives of chlorides As per USP ‘Complies Le General < 191 > meets the requirement 4 | Water content by KF_| Not more than anhydrous form 2.0% and 95% | ____| hydrous form 5.0 - 11.0 % i _ 3 | Solubility Freely soluble in water and insoluble in | Complies Z dichloromethane. | 6 __| Heavy metals NMT 20 ppm Complies 7 | Palladium (pd) [NMT 10 ppm | 14 ppm content by ICP : it [Residue on ignition | NMT 0.10% ww 0.02% PREPARED BY _ CHECKED BY APPROVED BY foun yan mae Beno} whom Zoro o4 IE Indira Nair ‘Vasudeo Desai Dhananjay Pat Sr. Executive Q.C. L Asst. Manager Q.C. Manager Q.A/Q.C. Reference SOP No. : QCP/043_— [Format No. : QCP/043/FO1 Marketing office: Lotus Corporate Park, C Wing, Floor 15, Western Express Highway, Goregaon (East), Mumbai 400 063 Maharashtra, India | (+91 22) 62505200 sgistered office: E-12, East Site, Atul 396 020, Gujarat, India CIN: U242306}1997PLCO32369 6ws tut Atul Bioscience Ltd Plot N-37, Additional Ambernath Industral Area, MIDC, Anand Nagar MMR Zone-tI, Ambemath (East) 421 506, Maharashtra, India pharma@atui.coin | www.etulbio.co.in CERTIFICATE OF ANALYSIS VALACYCLOVIR HYDROCHLORIDE USP Page 2/3, BATCH NO. : FG0S92100001 DATE OF MEG. : APR-2021 BATCH SIZE : 191KG RETEST DATE : MAR-2024 ANALYTICAL REPORT NO. : MUI/2122/QCP/FGQ/00028 DATE OF ANALYSIS 10/05/21 CONSIGNEE MEMPHIS PRODUCTS S.A. DISPATCH QUANTITY : 50KG SR. TEST SPECIFICATION RESULT No. 9 | Organic Impurity Valacyclovir related comp-D : NA Complies Procedure-1 Valacyclovir related comp-E : NMT 0.20% ND* Valacyclovir related comp-F : NMT 0.10% ND* ee Valacyclovir related comp-G : NMT 0.05% EEND? Bue 10 | Organic Impurity Guanine : NA ‘Complies Procedure-2 Complies ‘Acyclovir alaninate : NMT 0.20 % ND* Valacyclovir related comp-C : NMT 0.30% 0.01% Acyclovir related comp-A : NA Complies Valacyclovir related comp-D : NMT 0.50 % ND* Acyclovir isoleucinate : NMT 0.20% ND* ‘N-Formyl valacyclovir : NMT 0.80 % 0.19% Guaninyl valacyclovir : NMT 0.20 % ND* Bis valacyclovir : NMT 0.30 % ND* Any unspecified impurity : NMT 0.10 % ___0.04% Tl | Organic Impurity Guanine and acyclovir : NMT 2.0% 0.7% Procedure-3 Acyclovir related comp-A : NMT 0.20 % 0.01% - D-Valacyclovir : NMT 3.0% __ND*__ PREPARED BY _ CHECKED BY —_] APPROVED BY Ce yuna, Bart “Ban 8/2 frhoh 22F io) 4 Tndira Nair Vasudeo Desai Dhananjay Patil Sr. Executive Q.C. Asst, Manager Q.C. ___ Manager Q.A/Q.C. (043 Format No. : QCP/043/FOL [Reference SOP No. : Q Marketing office: Lotus Corporate Park, C Wing, Floor 15, Western Express Highway, Goregaon (East), Mumbai 400 063 Maharashtra, India | (+91 22) 62505200 Registered office: E-12, East Site, Atul 396 020, Gujarat, India CIN: U24230G1997PLCO32369& Gtk Atul Bioscience Ltd Plot N-37, Additional Ambernath Industrial Area, MIDC, Anand Nagar MMR Zone-Il, Ambernath (East) 421 506, Maharashtra, India pharma@atul.co.in | www.atulbio.co.in CERTIFICATE OF ANALYSIS VALACYCLOVIR HYDROCHLORIDE USP Page 3/3 BATCH NO. FG0592100001 DATE OF MFG. APR-2021 BATCH SIZE 191 KG RETEST DATE MAR-2024 ANALYTICAL REPORT NO. : MUI/2122/QCP/FGQ/00028 DATE OF ANALYSIS: 10/05/21 CONSIGNEE : MEMPHIS PRODUCTS S.A. DISPATCH QUANTITY : 50KG TEST SPECIFICATION RESULT 12 | Total Organic Impurity (sum ofall NMT 5.0% 1.0% [ organic impurity procedure 1,2 and 3) 13 | Assay by HPLC (on Anhydrous basis | 95.0% to 102.0% wiw 983% and solvent free basis) _ Additional Tests 14 [Residual Solvents Methanol: NMT 3000 ppm 19 ppm Acetone : NMT 5000 ppm I ppm | Isopropyl alcohol : NMT 5000 ppm 289 ppm Benzene : NMT 2 ppm ‘ND* Toluene : NMT 890 ppm 1 ppm ___| Dimethyl formamide : NMT 880 ppm 28 ppm ND*: Not Detected Remark: The product complies as per USP specification of Valacyclovir Hydrochloride ~ FP/026-01 PREPARED BY “CHECKED BY ‘APPROVED BY . WBonb lotuio ange see olay nom DFrol 24 _| Indira Nair Vasudeo Desai Dhananjay Patil Sr. Executive Q.C. | Asst, Manager Q.C. Manager Q.A/Q.C._} (Reference SOP No. : QCP/043 [Format No. : QCP/043/FOL : Lotus Corporate Park, C Wing, Floor 15, Western Express Highway, Goregaon (East), Mumbai 400 063, Maharashtra, India | (+91 22) 62505200 Registered office: E-12, East Site, Atul 396 020, Gujarat, India CIN: U24230GJ1997PLCO32369 G