ANALYSES and BIOANALYSIS – ACTIVE INGREDIENTS and METABOLITES

The Biogalenys laboratory carries out bioanalysis for preclinical studies.

Routine analyses for the pharmaceutical and cosmetic industries.

Biogalenys develops studies by using methods that are adapted to each project, validates these in line with recommendations and transfers them. 

Content/container compatibility.

·         Content/container compatibility studies (ISO 10093 and Japanese Pharmacopoeia)

          – Theoretical studies of potential extractables based on the additives list provided.

          – Production of extractables in 4 ranges of polarity.

          – Chemical analyses

          – Production of a list of extractables where the annotation and identification exceeds the AET (Analytical Evaluation Threshold).

          – Extractables risk assessment, quantification of safety margins

          – Leachables production in the finished product

          – Analysis and production of a list of leachables

          – Annotation and identification of leachables that exceed the AET.

          – Analysis of the ultimate risk of leachables, quantification of safety margins

          – Preparation of a final report in English by our expert attesting to the compatibility or non-compatibility of packaging.

Our laboratory is ISO 9001 and ISO 22716 certified.