Stability Tests Chemical and Pharmaceutical Industries

Stability Tests

Chemical industries, such as: pharmaceutical, veterinary, cosmetic, and personal care, among others, need to carry out stability tests of their products, which are a set of tests projected to obtain information on the products stability aiming to define its validity and period of usage in the specified packing and storage conditions.

The validity term of a product to be marketed in Brazil is determined by a stability study of long duration, according to the defined parameters. On the registration occasion it may be granted a provisional validity term or 24 months, if the 12 months duration long stability study report or the stability study report is accelerated to 6 months accompanied by the long term study preliminary results.

Accelerated Stability Study

Study designed to accelerate the chemical degradation and/or physical changes of a pharmaceutical product in forced storage conditions. The data obtained, including that derived from the long term studies, may be used to evaluate the prolonged chemical and physical effects in non-accelerated conditions and to evaluate the impact of short exposures to the conditions out of those established in the product label, which may occur during the transportation.

Monitoring Stability Study

Study carried out to verify if the pharmaceutical product maintains its physical, chemical, biological, and microbiological characteristics and the results obtained in the long term stability studies.

Long Term Stability

Study designed to verify the physical, chemical, biological and microbiological conditions of a pharmaceutical product during and, optionally, after the expected validity term. The results are used to establish or confirm the validity term and recommend the storage conditions.

The stability studies within the industries are increasingly more exigent by the regulatory agencies. The non-reliability of the data monitored by the equipment may cause the records and a lot of money losses. This without talking about the need to suspend all tests. Mecalor equipments are designed in accordance to the specification of each regulatory agency. This way we guarantee the companies the qualification of our equipments in all situations.