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Ylva Roddis
Stability studies
RISE offers stability studies for quality evaluation of a product or substance during storage.
Samples are held at 25°C/60%RH, 40°C/75%RH, 5°C or -18°C in validated climate cabinets/fridge-freezers with continuous monitoring, temperature and humidity log.
Studies performed GMP according to ICH Guidelines on drug substance/product, or exploratory.
Purpose
Stability studies are performed on chemical substances and on products such as pharmaceuticals, food, beverages and cosmetics to map the quality of the material over time. Factors that may affect quality include temperature, humidity and light. The result of the studies can be used to determine shelf-life, re-test date or recommended storage conditions.
Method
Representative samples of the material, with a specified quality by reference to parameters such as appearance, content, chemical purity, pH, are placed in specific environments over a selected period of time. The quality of the material is monitored during the period by sampling at certain times, the samples are analysed according to the specified quality parameters and results are compared with the original values.
RISE conducts both regulatory GMP studies according to ICH guidelines (ICH Q1A), or exploratory studies for research and development purposes. Both short-term studies (weeks) and long-term studies (several years) are possible.
RISE can offer the following environments for stability studies:
- 25°C±2°C / 60%±5% RH, standard
- 40°C±2°C / 75%±5% RH, accelerated
- 5°C±3°C, fridge
- -20°C±5°C, freezer
Climate cabinets have controlled temperature and humidity, fridge/freezers controlled temperature. They are qualified according to GMP requirements and placed in a room only accessible to authorized personnel. Humidity and temperature are electronically logged and stored in cloud storage in a web-based system. In the event of temperature or humidity outside specified interval, the system alerts responsible personnel via e-mail or text message around the clock.
RISE can also perform several types of analyses according to GMP on sampled material, e.g. assay and purity (LC, GC, NMR), appearance, water content (KF), pH. Samples can also be sent to external laboratories.
We can also develop and validate stability-indicating analysis methods, including forced degradation where the substance/product is exposed to heat, light, acid, base and oxidizing agent to induce formation of eventual degradation products.
Delivery
A study plan is agreed upon with the customer before the start of the study. Interim reports can be issued during the course of the study and a summary stability report after study completion.
