Laboratory Testing Services

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USP 1057, ISO 15883-1, AAMI ST98, Ph.Eur. 2.5.33, 1001105, 1001106, 1001109, 1001110, 1001111, 1001116, 1001124, 1001125, 100421, 1007023, 1007030, 100706
Chemistry - Residual proteins - analysis

BCA assay after extraction in 1% Triton x100 solution
ISO 10993-18, EU 10/2011, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 100421, 1007023, 100706
Chemistry - BDDE analysis

GC-MS analysis for butanediol diglycidyl ether
USP 1057, ISO 15883-1, AAMI ST98, Ph.Eur. 2.5.33, 1001107, 1001108, 1001110, 1001113, 1001116, 100423
Chemistry - Residual Proteins - Method validation

Recovery validation with BSA spike, 3 concentration levels
ISO 10993-18, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 100421, 1007023, 1007030
THC/CBD complete analysis

GC-MS for cannabinoid profile
ISO 10993-12, ISO 9377-2, 1001105, 1001106, 1001107, 1001110, 1001113, 1001124, 1001125, 100421, 1007023, 1007030, 100706
Chemistry - Total Hydrocarbons (THC) - analysis

Hexane extraction 24h, GC-MS quantification
ISO 15883-1, AAMI ST98, 1001107, 1001108, 1001109, 1001110, 1001113, 100423
Chemistry - Residual hemoglobin - method validation

Recovery study with hemoglobin spike at 3 levels
ISO 16232, 1001105, 1001106, 1001107, 1001110, 1001111, 1001125, 100405, 100421, 100423, 1006061, 10062341, 1007023, 1007030, 100706
Chemistry - Morpho-chemical analysis of particles - 1st sample

Particle extraction, SEM imaging + EDX elemental mapping
ISO 16232, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 100405, 100421, 100423, 1006061, 10062341, 1007023, 1007030, 100706
Chemistry - Morpho-chemical analysis of particles - additional samples

Additional SEM-EDX analysis on subsequent samples
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
Ph.Eur. 2.9.19, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169, USP 788, ISO 21501-3, AAMI TIR42, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 100405, 100423, 1007023, 1007030, 100706
Cleaning - Sub-visible particles - USP 788, EP 2.9.19 - analysis

Extraction in particle-free water, light obscuration counting
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
ISO 10993-18, USP 231, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 1002119, 100421, 1006071, 1006072, 1006073, 1007030, 100706
Chemistry - Tenax Specific migration - Full package testing

Acid digestion, ICP-MS for heavy metals

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