Search results - 4 results

Pyrogen testing of phage therapeutic products

is pivotal to limit the risk of non-endotoxin contamination. These pyrogens can be detected by the monocyte activation test (MAT), which employs human blood cells to quantify pyrogenicity in vitro. In ...

The GEONs API-fingerprint program: Tackling falsifications of APIs

API testing within the network is limited, compared to the surveillance of finished products. To tackle the issue of falsified API detection the API-working group (API- WG) of the GEON organizes ...

Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium

about 35% of the samples contained known and/or unknown impurities beyond the Ph. Eur. limits [3]. Concerning the dissolution tests, 47% of samples were not compliant as the amount of drug released is ...

How to determine acceptability limits based on biological variation in External Quality Assesment Schemes (EQAS): lymphocyte subsets as a case study

Publication Type: Scientific poster, presentation or proceeding Authors: Mohamed Rida Soumali Source: EQALM meeting 2015, NA, Issue EQALM, European Organisation For External Quality Assurance Providers in Laboratory Medicine, NA (2015) Keywords: a AS Case ...

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