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    CoA 1L87YDB(PTOI)

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    10 views5 pages

    CoA 1L87YDB (PTOI)

    Uploaded by

    wisang geni

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 5
    @ Otsuka CERTIFICATE OF ANALYSIS Product Name Abilify Maintena DCS 300mg “Aripiprazole for extended release injectable suspension 300 mg Lot No. 1L87YDB Quantity 2 256 syringes Date of Production : December 18, 2021 Date of Analysis ‘March 23, 2022 Expiry date December 2024 Specification 2 WA'32-04 Manufacturing site: ‘Tokushima Wajiki Factory API Origin Valdepharm Test Item Specification Result [No damage or crazing on the front assembly, glass cartridge, finger grip and plunger rod. ‘Sterile Water for Injection (SWFD: clear and colorless Description liquid; Complies Identification by HPLC-PDA, pH Identification by XRPD (monohydrate) Impurities/Degradation Products Li Polymorph (Anhydrous Type-1) it Test for Limit Test for Polymorph (Anhydrous Type-IV) Water content Extractable volume Lyophilized cake: white to off-white cakes Reconstituted suspension: white to off-white fluid suspension Spectrum and retention time are comparable to those of | [Exhibits peaks at: 20 Approximately 12.7, 17.5, 18.8, 22.6, 25.0 and 27.6 Individual: $ 0.2% Total: < 1.0% < 10% > 1.5mL, Complies 1 Complies Individual : 0.0% Total : 0.0 % Complies Complies 1.6 mL Otsuka Pharmaceutical Co,Ltd. ‘Quaty Conte! Section (Tokushiva Wajk Facto), Qvalty Cont Department, Quay Heseqverters Soe-2 ea Olsubo, Kony, Noka-on,Naka-pun Tokushima 771-520, Japan Phove:*8%-88462-9181, Fax 50 pm; < 10 oe (low-magnitic greater : 0 Complies with USP Complies ‘After 15 minutes: 42::10% ‘After 15 minutes: 42 % Dissolution After 2 hours: 65210% ‘After 2 hours: 71 % After 8 hours: = 85% After 8 hours : 102% i. Ae 23G : 10.8N = 2 Pushing force: < 40.0'N 22G : 1S3N ree 21G: 13.1N Container/Closure No water leaka nt assembly's fitting part Integrity Test: Water royce oe Complies Pressure Test ee : Container/Closure Integrity Test: Dye A Complies Immersion Test-1__ ee - Container/Closure Integrity Test: Dye B Complies Immersion Test-2 A= In the rear chamber between Middle and End Stoppers, the color of the sterile water for injection (SWFI) with white background is less intense in blue color than that of the comparative solution, No SWFI ingress into the front chamber containing the lyophilized cake through Middle Stopper is confirmed. No dye ingress into the front chamber through Front ‘Stopper is observed. BB = In the rear chamber between Middle and End Stoppers, the color of the sterile water for injection (SWFT) with white background is less intense in blue color than that of the comparative solution. No SWET ingress into the front chamber containing the lyophilized cake through Middle Stopper is confirmed. No dye ingress into the contact part of the top of the ‘uiside diameter of Luer-lock in Over-cap and Over-cap is observed, Otsuka Pharmaceutical Co,Ltd. ‘Quatty Control Seton (Tokushima WajkiFacton), Quality Conral Department, Quality Headquarters ‘3052 Aza Otsube, Ken Naka'Sho Nake gun, Tokushima 71/5208, Japan Phone *81-384:62°3161, Fax *81-884-62-1790, Page 2065 @ aiscKc Product Name CERTIFICATE OF ANALYSIS Abilify Maintena DCS 300mg Aripiprazole for extonded release injectable suspension 300 mg Lot No. ILSTYDB Removal force of Bacterial Endotoxins <0.5 BUimg <40.0N 2 Over-cap ha Sterility ‘Complies with USP Complies Assay 90.0-110.0% 102.7% <0.5 U/mg issued oy (Dtasene [a frabash- Masanori Takahashi Quality Control Manager ‘Tokushima Wajiki Factory Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Co,Ltd. (uy Conirol Section Tokushera Wejki Facto), Quality Conte Deparment. Quaity Headquarters abo aiet, Fax: +81-99462-1709, 5306-2 Aza Otsubo, Konu, Naka-

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