All sterile compounded preparations are produced under 503B of the FD&C act (503B Guidance), following current Good Manufacturing Practices (cGMP) and meet or exceed USP :
- Stability-indicating studies have been performed on all products to ensure their safety and integrity throughout their beyond use date.
- Microbiological and chemistry testing (including sterility, endotoxin, potency, pH, and particle size for suspensions) is completed on each batch prior to product release.
- Beyond Use Dates (BUDs) are established based on product-specific stability testing of both chemical and microbiological characteristics.
A Certificate of Analysis (CoA), detailing results from batch testing, can be provided for each of the products on request.