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    Resomer LT 706 S - D220700029

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    Aguedo Aragones
    This certificate of analysis summarizes the test results for a batch of RESOMER LT 706 S 1000G. The batch conforms to specifications for appearance, odor, identity, composition, viscosity, residual substances and elemental impurities. The product was manufactured according to current Good Manufacturing Practices. Test results are within listed minimum and maximum levels for all properties examined.

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    Resomer LT 706 S - D220700029

    Uploaded by

    Aguedo Aragones
    42 views2 pages
    This certificate of analysis summarizes the test results for a batch of RESOMER LT 706 S 1000G. The batch conforms to specifications for appearance, odor, identity, composition, viscosity, residual substances and elemental impurities. The product was manufactured according to current Good Manufacturing Practices. Test results are within listed minimum and maximum levels for all properties examined.

    Original Description:

    Gostaria de usar a referida Norma para avaliar a viscosidade do Polímero conforme anexo.

    Original Title

    Resomer LT 706 S_D220700029

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    This certificate of analysis summarizes the test results for a batch of RESOMER LT 706 S 1000G. The batch conforms to specifications for appearance, odor, identity, composition, viscosity, residual substances and elemental impurities. The product was manufactured according to current Good Manufacturing Practices. Test results are within listed minimum and maximum levels for all properties examined.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    42 views2 pages

    Resomer LT 706 S - D220700029

    Uploaded by

    Aguedo Aragones
    This certificate of analysis summarizes the test results for a batch of RESOMER LT 706 S 1000G. The batch conforms to specifications for appearance, odor, identity, composition, viscosity, residual substances and elemental impurities. The product was manufactured according to current Good Manufacturing Practices. Test results are within listed minimum and maximum levels for all properties examined.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Page 1 of 2

    Evonik Operations GmbH - D-64275 Darmstadt


    Certificate of Analysis
    EVONIK BRASIL LTDA. Date 06.09.2022
    EBL - WAREHOUSE GUARULHOS
    AV JUSTINO DE MAIO 365 Delivery Number / Item 3008814935 / 000001
    CUMBICA
    Order Number / Item 46299788 / 000020
    GUARULHOS - SP
    07222-000 Contact Person Dagmar Hill
    BRAZIL
    E-Mail [email protected]

    Customer Number 501312

    Product RESOMER LT 706 S 1000G


    Quantity 5 KG = 5 EA
    Batch D220700029
    Production date 07/2022
    Stability at least until 07/2027
    end of

    Specification
    Property Test Method Unit Value Min. Max.
    Appearance colour Visual test conforms white to off-white

    Appearance shape Visual test conforms granules

    Odour Sensory test conforms nearly odourless

    Identity NMR-spectrum NMR spectroscopy conforms Corr. to ref. spec.

    Polymer composition L-Lactide NMR spectroscopy %(w/w) 69 68 72

    Polymer composition TMC NMR spectroscopy %(w/w) 31 28 32

    Inherent viscosity (25°C,0.1%,CHCl3) Inherent viscosity dl/g 1,5 1,2 1,6

    Water Coulom. determination %(w/w) 0,25 <= 0,5

    Residual monomer total Gas chromatography %(w/w) < 0,1 <= 1

    Residual solvent toluene Gas chromatography ppm <5 890

    Tin ICP-MS ppm 24 100

    Sulfated ash Limit test conforms <= 0,1 % (w/w)

    PS equivalent mol.weight Mw Size excl. chrom. g/mol 166000 not specified

    PS equivalent mol.weight Mn Size excl. chrom. g/mol 94400 not specified

    PS equivalent mol.weight Mw/Mn Size excl. chrom. 1,8 not specified

    Evonik Operations GmbH Chairman of the supervisory board: Dr. Harald Schwager Registered office: Essen Tel.: +49 201 177-01
    Rellinghauser Str. 1-11 Board of Directors: Dr. Joachim Dahm, Johann-Caspar Register court: Essen local court Fax: +49 201 177-3475
    45128 Essen Gammelin, Lauren Kjeldsen, Maike Schuh, Commercial registry: B 20227 www.evonik.com
    Germany Alexandra Schwarz Tax-Id.: 112/5708/0516
    Product RESOMER LT 706 S 1000G Page 2 of 2
    Date 06.09.2022
    Batch D220700029
    Delivery Number / Item 3008814935 / 000001

    Elemental Impurities - conforms to ICH Q3D requirements. Not measured at each lot.

    The Product conforms to the requirements of Evonik Operations GmbH, including ISO 9001:2015. The customer is not released from
    the obligation to conduct careful inspection and testing of incoming products.

    GMP Compliance:
    The product is manufactured according to current Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients as
    published by IPEC-PQG.

    Evonik Operations GmbH

    Michael Kübitz Boris Glasbrenner


    (Head of Global Sales Support (Head QA Operations
    Health Care) Quality Darmstadt/Weiterstadt
    Health Care)
    (Written by computer and therefore not signed)
    *** End ***

    Evonik Operations GmbH Chairman of the supervisory board: Dr. Harald Schwager Registered office: Essen Tel.: +49 201 177-01
    Rellinghauser Str. 1-11 Board of Directors: Dr. Joachim Dahm, Johann-Caspar Register court: Essen local court Fax: +49 201 177-3475
    45128 Essen Gammelin, Lauren Kjeldsen, Maike Schuh, Commercial registry: B 20227 www.evonik.com
    Germany Alexandra Schwarz Tax-Id.: 112/5708/0516

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