Gs oy A my oT EsicchPharma Co. 1d. 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea Tel. +82(31)831-4800, Fax. +82(31)831-4801 Certificate of Analysis RefNo, : BALB-20191014-03 Batch No. : ALBB318EA0L Product _ : Policresulen (50 % solution) Mfg. Date: 2018.04.23 Formula: CrsH2«O2Ss Retest Date : 2021.04.22 MW. : 588.61 Quantity: 100.0 kg We hereby certify that the below results are true and correct. KPD/ KP Clear, reddish brown liquid, almost, odorless ‘Clear, reddish brown liquid, almost odorless ‘DESCRIPTION IDENTIFICATION Identification I | Purple color appears. Conforms KP / KP (Qualitative test) Identification | A white precipitate is produced. Conforms KP / KP (Qualitative test) Identification I J A solidified precipitate of gelatin is Conforms, KP / KP (Qualitative test) produced. Identification IV Blue color appears in the solution, Conforms KP / KP (Qualitative tet) Identification V | Absorption maximum occurs around 283 nm. | Absorption maximum occurs at KP / KP w) 281 nm. SPECIFIC GRAVITY | 3p: 1.206 ~ 1.226 1218 KP / KP PURITY Purity T (Sulfate) | (1) No turbidity is produced in 5 minutes. | Passed KP / KP (2) Not more than 2.5 96 Passed IHS® / PhEur® Purity 11 Garium) | No turbidity is produced in $ minutes. Passed KP / KP Purity II Gpeciic | Absorption maximum occurs at 281 nm, | Absorption maximum occurs at 282 KP / KP absorbance) and the specific absorbance at this iim, and the specific absorbance at wavelength is 70.0 ~ 820. this wavelength is 815. Active ingredients HS / KP [HPLC] = Polymers Not less than 45.0 Area% 462% = mCresol-6- | Not more than 70.0 ma/g 6548 mg/g sulfonic acid = mCresol-4- | Not more than 170.0 mg/g 100.79 mg/g sulfonic acid - mCresol-4 Not more than 15.0 mg/g 1449 mg/g disulfonic acid = Dicresulene Not less than 20.0 mg/g 45.44 mg/g Metacresol [HPLC] | Not more than 1.0 mg/q 034 mg/g IHS / KP Formaldehyde Not more than 1 ppm < Detection limit (OL: 0.04 ppm) | ICH® / KP IHPLC] ASSAY [Titration] _] 45.0 ~ 55.0 % (as is basis) 51.6% KP / KP. 5OP-Q013 A101 (1.1) Page 1 of 2a= op ASO ‘techPharmn Ca. tad 25, Barangongdan-ro, Hyangnamn-eup, Hwaseong-si, Gyeonggi-do, Korea Tel. +82(31)831-4000, Fox, +82(31)831-4801 Certificate of Analysis Ref No. : BALB-20191014-03 Batch No, : ALBB318EA01 Product _ : Policresulen (50 % solution) Mfg. Date: 2018.04.23 Formula: CraHzeOSs Retest Date : 2021.04.22 MW. 2588.61 Quantity: 100.0 kg We hereby certify that the below results are true and correct. ICH / KP RESIDUAL SOLVENT I (ec) = Chloroform RESIDUAL SOLVENT IL Isc) ~ Methanol MICROBIAL ENUMERATION TEST| ~ TAMC Not more than 60 ppm << Detection limit (OL: 04 ppm) ICH / KP Not more than 3000 ppm 36 ppm Pheur. / Pur ‘Not more than 100 CFU/mL O.cFU/mL = TYMC Not more than 10 CFU/mt. o.crusmt TESTS FOR MICRO-ORGANISMS| Pseudomonas ‘Absence of Pseudomonas aeruginosa in 1 mb | Absence Phur. / PhEut aeruginosa Staphylococcus _| Absence of Staphylococcus aureus in 1 mL} Absence Phun. / PhEur Candida albicans "DKP : Korean Pharmacopoeia 2 14S : In-house specification 2) Phfur : European Pharmacopoeia © DL : Detection limit SICH :ICH guideline € Packaging and storage conditions: Tight cantainr, store at 1 ~ 30°C Ph.éur / Pheur Absence of Candida albicans in 1 mt Absence Signature Issued Date : 2019.10.14 Jinoon OH (E-mail : bossiniS @estechpharma.com) / RA Manager SOP No. : SOP-Q013 #01 (1.1) Page 2 of 2