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Stability testing

We offer the complete range of services for stability testing.

We offer you the complete range of services from storage to analytics and microbiology. We support you in the planning of stability testing and also in the development and validation of test methods. The appropriately qualified laboratory facilities are available for these tasks.

Storage

Establishing the standard climate conditions for storage.

Storage is carried out in accordance with ICH guidelines. We use cGMP qualified climate chambers with current technology.

  • 5°C
  • 25°C/60% RH
  • 30°C/65%RH
  • 30°C/75% RH
  • 40°C/75% RH

Back up and safety measures for storage

  • Continuous monitoring of the climate cabinets and alarming
  • Use of the secured power supply of a large chemical park
  • Reserve capacities for relocations
  • Our services:
  • Support with test planning
  • Monitoring of test times and punctual removal from storage
  • Documentation of the removal from storage
  • Continuous recording of climatic conditions
  • Examination of the test samples
  • Documentation of results according to your specifications

Microbiology

Approvals of the IMQ

  • Testing in accordance with § 14 Para. 4 of the German Medicines Act (GMP – certificate of the Düsseldorf district government)
  • Microbiological testing of non-sterile products
  • LAL test (test for endotoxins/gel clot test)
  • Microbiological testing of purified water for pharmaceutical purposes

Analytics

We offer the following analytical techniques as standard for checking stability-relevant parameters:

  • HPLC, UPLC, GC, LC/MS, GC/MS
  • UV/VIS, NMR, XRD
  • Dissolution, degradation, fracture strength, colour, water content, titration

Service details

  • Method development, validation and method transfer
  • Performance of tests
  • Documentation according to GMP
  • Identification of degradation products

Leitung Institut für Biomonitoring

Dr. Laura Tretzel
Dr. Laura Tretzel
+49 152 21842628[email protected]

Geb. Q 18

CHEMPARK Leverkusen

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