Laboratory Testing Services

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ISO 10993-12, Ph.Eur. 2.2.44, USP 643, EN 1484, 1001105, 1001106, 1001109, 1001113, 1001116, 100423, 1006229
Chemistry - TOC (medical device) - method validation

Recovery study with sucrose spike in extraction water
Ph.Eur. 2.2.3, USP 643
Chemistry - nonvolatile residues by gravimetry

Evaporation of extract, gravimetric determination
Ph.Eur. 2.2.44, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169, USP 643, EN 1484, ASTM G136-03, 1001106, 1001107, 1001108, 1001110, 1001111, 1001124, 1001125, 100421, 1007023, 1007030, 100706
Chemistry - TOC - water analysis

Direct water analysis by combustion/oxidation method
ISO 10993-12, Ph.Eur. 2.2.44, USP 643, EN 1484, 1001105, 1001107, 1001108, 1001110, 1001111, 1001124, 1001125, 100421, 1006229, 1007023, 1007030, 100706
Chemistry - TOC (medical device) - analysis

72h extraction at 37°C or 50°C, TOC measurement of extract

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