Stability Studies According to ICH

Stabilitätsprüfungen ICH

Stability tests prove the stability of pharmaceutical products during storage and transportation. In addition, the stability of intermediates and active ingredients is tested.

CURRENTA Analytics performs stability tests for product approvals and to support product and process development. This involves complying with specified regulations and international standards (ICH, cGMP).

Our services in the area of stability studies

We offer you a complete range of services from storage and analytics to microbiology. We support you in planning stability tests and in developing and validating test methods. Modern and approved laboratory facilities are available for these tasks.

Services in detail

  • Method development, validation and method transfer
  • Performance of tests
  • Documentation in accordance with GMP
  • Identifying degradation products

 

Storage

Determining standard climatic conditions for storage

Klimaschränke

Storage is in accordance with ICH guidelines. We use state-of-the-art climate chamber approved in accordance with cGMP.

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

Backup and security measures for storage

  • Continuous monitoring of climate chamber and alarm system
  • Use of the secure power supply of a large chemical park
  • Reserve capacities for stock transfers

Our services:

  • Support in planning studies
  • Monitoring test points and timely release from storage
  • Documentation of release from storage
  • Continuous recording of climatic conditions
  • Analyzing test samples
  • Documenting results according to your specifications
Microbiology

IMQ approvals

Petrischale mit Bakterienkolonien
  • Tests in accordance with § 14 (4) of the German Medicines Act (GMP – certification by Bezirksregierung Düsseldorf [Dusseldorf district authority])
  • Microbiological tests of non-sterile products
  • LAL test (test for endotoxins / gel clot test)
  • Microbiological testing of purified water for pharmaceutical purposes
Analytics

Analytical methods

Stabilitätsprüfungen ICH

We offer the following analytical methods to test stability-related parameters as standard:

  • HPLC, UPLC, GC, LC/MS, GC/MS
  • UV/VIS, NMR, XRD
  • Dissolution, degradation, resistance to breaking, color, water content, titration
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