Stability studies of medicinal products and feed additives
A stability study justifies the shelf life and storage conditions of a medicinal product or feed additive. Stability data are mandatory for the registration dossier.
Types of studies
- Long-term testing: storage under the conditions specified by the manufacturer, with analysis at control points throughout the claimed shelf life.
- Accelerated testing: storage at elevated temperature and humidity to predict stability.
- In-use stability: the period of use after the package is first opened or the solution is prepared.
- Stability in feed and water: for premixes, feed additives and products given with feed or water.
What is monitored
- Content of active substances.
- Degradation products and related substances.
- Appearance and physicochemical parameters according to the regulatory documentation.
How we work
- A study programme: storage conditions, control points, quality parameters.
- Placing samples into storage under the specified conditions.
- Analysis of the samples against the regulatory documentation at each control point.
- A report justifying the shelf life and storage conditions.
What the client receives
- A stability study programme (protocol).
- Interim results at each control point.
- A final report justifying the shelf life, storage conditions and in-use period after opening.
Timing and cost
Long-term testing lasts the entire claimed shelf life; accelerated testing takes several months. The cost depends on the number of batches, control points and quality parameters.
Why choose us
- Experience: more than 20 years of work with veterinary medicinal products and feed additives and over 10,000 completed studies.
- In-house laboratory: 170 units of analytical and test equipment, including chromatography–mass spectrometry.
- Full cycle: studies, laboratory analysis and registration dossier preparation in one company, with no time lost passing data between contractors.
- Transparency: an agreed plan and timeline, with interim results as the work progresses.
How to order
To get a quote and agree on the study design, contact Neurometrix specialists by phone at +7 903 613-00-79 or send a request to info@neirometrix.ru. We prepare a commercial proposal within two business days.
Frequently asked questions
Can a product be registered based on accelerated testing alone?
Accelerated testing can justify a provisional shelf life. Long-term testing continues in parallel, and its results confirm or adjust the shelf life.
How many batches need to be placed on stability?
As a rule, the study is performed on several batches of the product in its commercial packaging. The exact number of batches is determined by the registration requirements.
Does stability need to be studied after a packaging change?
Yes, packaging affects product stability, so stability data usually need to be confirmed after a change.
Can the shelf life of an already registered product be extended?
Yes, if long-term testing confirms the product is stable for a longer period. The results are used to vary the registration dossier.