Services > Pharmaceutical Quality Control

The department of Pharmaceutical Quality Control is characterised apart from the individual investigations by drug release on stability investigations.

Our services, used methods and experience are described in the following.

Services of the department Pharmaceutical Quality Control (GMP)
  • Investigations to the release of raw materials, bulk and final products
  • Stability investigations according to ICH
  • Physical-chemical tests according to the appropriate methods of the pharmacopoeia
  • Method development for the determination of the content as well as for the determination of the known and unknown impurities in raw materials, bulk and final products
  • Method validation according to ICH (including protocol, final report) for the determination of the content as well as for the determination of the known and unknown impurities in raw materials, bulk and final products
  • Determination of in vitro dissolution according to the appropriate methods of the pharmacopoeia
  • Investigations for the release of investigational medicinal products (IMPs)
  • Determination of in vitro dissolution for the characterisation of investigational medicinal products (IMPs) according to relevant guidelines, statistical analysis, calculations of in-vitro/in-vivo correlations (IVIVC)
Methods and Equipment
The main focus of used methods are based on pharmacopoeial methods, chromatography, capillary electrophoresis and coagulating analyses. The following techniques are used:
  • HPLC
  • GC-MS
  • LC-MS/MS
  • CE (Capillary electrophoresis)
  • SEC (Size-exclusion chromatography)
  • Photometry
  • Coagulometry
Beside the mentioned techniques and physicochemical methods of the pharmacopoeia, the following tests and methods are used:
  • Thin-layer chromatography
  • Dissolution test (paddle, basket, disk)
  • Friability
  • Karl Fischer Titration
  • Osmolarity
  • Particle size (microscope)
  • Apparent volume
  • Resistance to crushing of tablets
  • Loss on drying
  • Disintegration of tablets, capsules und suppositories
We offer stability tests under the following controlled ICH conditions (further conditions on request):
  • 25 °C / 60 % rH
  • 30 °C / 65 % rH
  • 40 °C / 75 % rH

The climate chambers are under continuous temperature control (validated software, annually calibrated, 24-hour centralised alarm system).

Experiences

The ACC GmbH Analytical Clinical Concepts is engaged in numerous release investigations.
So far, up to more than 180 batches of stability tests have now been investigated by us.

The methods are described in about 120 test instructions. New methods are continually
developed and validated. Depending on the drug formulation, we would be able to develop and
validate methods within 2-3 weeks

Up to now the following dosage forms have been investigated:
Creams, film-coated tablets, gels, granules, capsules, infusions, injections, pastes, powders, ointments, suppositories, suspensions, tablets, drops.

The investigated drugs cover the whole drug spectrum.