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Stability Testing

The laboratory DSI-pharm, assists manufacturers from initial pharmaceutical development and the stability testing of bulk or final products through to in-use stability studies, stability monitoring of post-marketing batches (on-going stability testing) and testing in connection with variations.

DSI-pharm’s services

• Regulation-compliant testing plans
• Import authorisation for international projects
• Storage according to ICH conditions
• Licence acc. to section 3 of the German Narcotic Drugs Act
• Coordination, analysis, evaluation and reporting
• Efficient planning and implementation of on-going stability studies
• QP interpretation of OOx results (OOS, OOT, OOE)

Stability testing is required in order to determine and validate the chemical and physical shelf-life under specific storage conditions (humidity, temperature). In the run-up to clinical studies, stability testing is used to ensure that the shelf life of a study drug is sufficient to last for the duration of the study. Long-term studies involving the finished product are required for marketing authorisation. Following this, manufacturers are legally obliged to undertake on-going stability studies on a regular basis, so that they are able to prove that the medicinal product in question can be used safely over the entire period of its shelf life.

In-use stability testing for multidose containers

Medicinal products and medical devices in multidose containers face a higher risk of contamination or degradation due to repeated opening, which is why a shelf life after first opening is given for these products. This shelf life is determined as part of in-use stability testing. Testing entails simulating actual use, such as everyday usage of the package, tube, spray can, applicator etc., as closely as possible. The product is inspected at specific intervals with regard to microbial, chemical and physical attributes.

Proof of the opened product’s quality is part of the marketing authorisation documents. In the process, it is necessary to prove in-use stability both at the beginning and at the end of the specified shelf life. Testing must therefore be devised at the same time as ICH long-term stability testing in order to prevent any loss of time.

The requirements of in-use stability testing are described in the CPMP Guideline CPMP/QWP/2934/99 from the European Medicines Agency (EMA). The guideline does not prescribe a specific test design. The design depends on the product’s use and packaging. DSI-pharm can help you create needs-based testing plans and is happy to advise you on batch selection.

ICH climatic zones for stability testing

No lifecycle without stability testing! The “expiry date” of a medicinal product not only supports the safe use of this product, but it can also open up new markets, for example, creating overseas opportunities.

Standard conditions

• Climatic zone II, 25°C/60% RH
• Intermediate conditions, 30°C/65% RH
• Accelerated testing, 40°C/75% RH

Refrigerated storage

• 2°C to 8°C

Special climactic zones

• Climactic zone I, 21°C/45% RH
• Climactic zone III, 30°C/35% RH
• Climactic zone IVa, 30°C/70% RH
• Climactic zone IVb, 30°C/75% RH

Freezer storage

• -20°C

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