Recommendations For Stability Testing and The Future Is Here

The AAHP office just Got a copy of the article, Stability Testing of Medicinal Products Based on Homeopathic Basics; this seemed in Pharmaceutical Industry. The article has been co-written by 8 co-workers of European firms, of which 5 are members, or associated with members, of the AAHP. The report covers the execution, in daily practice, of stability testing requirements. However, because of the special qualities of homeopathic products, the authors note that such testing should be restricted only to those conditions when appropriate. While the regulations mentioned in the article apply to the European Community, the exact concepts are applicable for homeopathic products everywhere.

The authors indicate Stability testing demonstrates how the quality of an active substance varies over time because of the effect of ecological factors, such as humidity and temperature. Retest periods are defined based on systematic equilibrium studies. However, the authors say, homeopathic products have a more intricate relationship to retest intervals, because they are sometimes final goods or an intermediate product for further processing.Thus, the attenuation of the most concentrated preparation [to a greater attenuation] is a production step leading is a new active substance or a new finished product, in accord with the definitions of Article 15 of Directive 2001/83. Therefore, always the individual manufacturing step is the beginning of a new re-rest period or fresh shelf-life.The authors go on to Give examples of the execution of Stability Testing requirements; those examples are based on the actual practices of companies producing homeopathic medications.

For the most focused homeopathic preparations e.g., tinctures, equilibrium over time could be assured so long as the monograph specifications continue to be fulfilled. The report discusses assays and microbiological testing and addresses circumstances when these aren’t relevant tests depending on the qualities of the homeopathic products.Addressing Intermediate goods, the authors divide these into two groups: those for which definitive materials are found and may be tested, and those for which there are not such substances present either as a result of source material or the level of attenuation. In the latter case, overall stability related properties are adequate, for which the authors propose appropriate parameters. Similarly, finished products could fall into the same two categories, and the authors give similar justifications and parameters.