Analytical Challenges from combination products.

January 24, 2018

Single entity combination products (SECP) present unique analytical challenges compared to the other types of combination devices.   Most notably, in a SECP the combining process and sterilization will most likely create impurities and degradants no observed in the individual component.   This is especially common for SECP contains drugs.

In addition, an SECP may have specific design features that need to measure to ensure proper functioning of the product.  For example, measuring the rate of the release of a drug could be a critical performance feature requiring a specific analytical method to evaluate.

Pine Lake Laboratories has a proven record of developing and validating analytical methods for single entity combination products.   We also have the necessary equipment and expertise to identify degradation products and impurities that are unique to single entity combination products.