Analytics

The labs are equipped for the control and stability studies of solid dosage forms as well as liquid and semi-solid dosage forms.

Quality control

ANALYSTES

Identification (HPLC, TLC, Colorimetric) • pH, density • Extractable volume, average volume • Water content (Karl Fischer) • Average mass, mass uniformity • Assay: active ingredient • Assay: preservatives • Assay: relative substances • Content uniformity • Content uniformity – mass variation  • Dissolution (spectrophotometer) • Microbiology • Sterility

Methods development

Assay method development or variation (HPLC, spectrophotometer, burette) • Assay method transfer • Dissolution method development or variation • Dissolution method transfer • Development of HPLC method for dissolution • Development of spectrometric method for dissolution • Water content method development.

BIOPOLE-2010-011

Analytical validation

Assay method validation according to ICH Q2R • Validation of HPLC and spectrometric method for dissolution

Data analysis using a 21CFR part 11 software •  Analysis of customer data

Stability studies

According to ICH conditions (25°C, 60% RH /30°C, 65% RH / 40°C, 75% RH / 5°C)

New equipment

Aptys acquires new equipment in order to extend its offer:

Download the list of equipment