Quality Control

The service profile of Quasaar GmbH primarily includes the quality control of pharmaceuticals (human and veterinary), active ingredients, raw materials and excipients.

Hereby the effectiveness and safety of the product for the protection of the patient or user is the prioritized goal.

For this purpose, mainly the latest analytical techniques are used, which for efficiency reasons have a high degree of automation. This is complemented by an extensive quality assurance system to ensure GMP compliance.

Equipment / Methods

Liquid chromatography:

HPLC / UPLC (Agilent, Merck-Hitachi)

Detectors: UV-VIS, PDA, fluorescence, light scattering (CAD)

HPLCAgilent

Drug Release:

Paddle & Basket (USP 1 & 2) automated systems

Mini paddle -enhancer-cell

special techniques, special dosage forms

Biopharmaceutical characterisation

disso

Gas chromatography:

GC / GC-HS (residual solvent, purity, automatic derivatisation)

 

Spektroscopy:

FTIR (Bruker), UV (Agilent)

Detector: FID

 

Titrators:

Ion analysis, content determination (Methrohm, Xylem-SI-Analytik)

 

Water determination / Karl-Fischer titration:

volumetric / coulometric, oven-methode (Metrohm)

TitrationPipettieren

Pharmaceutical-technical methods:

  • Disintegration
  • Breaking strength
  • Friability
  • Testing for visible / non-visible particles
  • Microscopic characterisation
  • Pharmacopoeia analysis
  • Identities
  • Limit value tests
  • Appearance
  • Content - assay
  • Purity - impurity profile
  • Ashing/digestion
  • Drying, evaporation loss
  • Clarity-colour-opalescence of solutions
  • Leak test
  • Packaging material tests
  • Uniformity of content
  • Average mass
  • Drop size
  • Acid, soap, hydroxyl, iodine number
  • Wet chemical methods
  • Filling volume
  • Thin Layer Chromatography
  • Sieve analysis
  • Viscometry

 

ZerfallIR

Standard methods:

  • Determination of pH value
  • Osmolarity
  • Polarimetry
  • Refractrometry
  • Density measurement
  • Solubility determination (pH-dependent)
  • Distribution coefficient

 

Special techniques:

  • XRPD (Outsourcing)
  • Material-specific function tests
  • Particle size distribution (also toxic substances)
  • Laser diffractrometry LD (Sympatec)
  • Dynamic Light Scattering DLS (Malvern)
  • Particle contamination
  • Testing of inhalers,
  • Permeation measurements of packaging materials
  • Microbiological investigations (outsourcing)

LDContainment