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Resomer LT 706 S - D220700029

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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Aguedo Aragones
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173 views2 pages

Resomer LT 706 S - D220700029

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.

Uploaded by

Aguedo Aragones
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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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