Stability Testing of Herbal Medicines

Inquiry

The stability of herbal medicines refers to the extent to which the chemical, physical and biological properties of herbal medicines change. Stability studies are one of the main elements in evaluating the quality of pharmaceutical products and occupy an essential position in the research, development, and registration management of pharmaceutical products. Lifeasible uses stability tests to examine the pattern of changes in the properties of herbal medicines over time under different environmental conditions (e.g., temperature, humidity, light, etc.) to understand and predict the trend of stability of medicines and to support the determination of requirements for the production, packaging, storage, and transport of medicines and the establishment of expiry dates.

Stability testing of herbal medicines

Influencing factors test

We investigate the stability of drugs under severe conditions and understand the factors that affect their stability and the changes in the ingredients they contain. This provides a basis for formulation design, process selection, selection of packaging materials and containers, determination of storage conditions, and control of the substances involved. It also provides a reference for the temperature and humidity conditions used in accelerated and long-term tests. This will be carried out according to different research purposes, taking into account the physical and chemical properties of the herb, the characteristics of the dosage form, and the specific prescription and process conditions.

High-temperature tests
High humidity tests
Intense light exposure test

Accelerated test

The purpose of our stability tests under accelerated conditions is to understand the chemical, physical and biological changes in raw materials or formulations in a relatively short period. It provides a test basis for formulation design, quality evaluation, packaging, transport, and storage conditions, as well as a preliminary prediction of the stability of the sample.

Long-term test

Stability tests are carried out under conditions close to the actual storage of the drug to provide a basis for the formulation of the expiry date of the drug.

In-use stability test

Stability studies are staged and have different purposes at different stages. They generally begin in pre-clinical studies, continue throughout the research and development of the drug, and continue after the drug has been marketed.

Applications

Determination of storage conditions
Determination of packaging materials/containers
Determination of expiry dates

Lifeasible sets the items (or indicators) to be investigated in stability studies according to the characteristics of the ingredients and/or preparations contained and the quality requirements. We will assist you in selecting items that are susceptible to change during the storage of the medicine and may affect the quality, safety, and efficacy of the medicine so that the stability of the herbal medicine can be evaluated objectively and comprehensively.

Items to examine for stability testing - Lifeasible

To determine the stability of herbs, comparative studies are carried out on the consistency of ingredients contained in samples from the same batch at different sampling time points and from different batches. Please feel free to contact us for more information.

For research or industrial raw materials, not for personal medical use!