Bioglan Development

Stability studies

The stability issue is faced in all parts of product development. The storage capabilities at Bioglan are fully compliant with ICH guidelines.

We offer:

  • Stability study design and monitoring according to ICH (International Conference on Harmonization) guidelines
  • Accelerated stability studies during product development
  • Stability testing of API (active pharmaceutical ingredient) and finished product
  • Screening stability studies during product development
  • Trend analysis and suggestion for expiry date
  • Stability reports
  • Generation of documentation for Clinical Trial Applications (CTA, EU)/New Drug Applications (NDA, USA)

Storage conditions

General case

Condition Temperature Humidity control
Freezer -20°C ± 5°C
Refrigerator 5°C ±3°C
Long term 25°C ± 2°C 60% RH ± 5% RH
Intermediate 30°C ± 2°C 65% RH ± 5% RH
Accelerated 40°C ± 2°C 75% RH ± 5% RH

Semi-permeable containers

Condition Temperature Humidity control
Long term 25°C ± 2°C 40% RH ± 5% RH
Intermediate 30°C ± 2°C 60% RH ± 5% RH
Accelerated 40°C ± 2°C ≤ 25% RH
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