Test Services

Dissolution

BACKGROUND
Definition: Dissolution is the process of dissolving a solid substance in a defined liquid solution under controlled mixing, solution and temperature conditions. This test is typically performed on solid dosage forms including but not limited to capsules and tablets, to validate immediate, extended or delayed release claims.

OUR METHODOLOGY
DYNALABS employs programmable automated dissolution apparatus to perform dissolution testing. The testing parameters are defined in the USP for those compounds with a monograph. For these compounds that do not have a monograph in the USP, DYNALABS provides a service to develop and validate the dissolution method. All methods are developed and validated according to the standards delineated in USP <805> and USP <1225>.

The number of samples and time points assayed is established during the experimental design phase of the project. Portions of solution are sampled and analyzed using appropriate potency testing methodology to determine the level of dissolution.

Specifications for dissolution are expressed as a minimum percent of labeled active dissolves within a specified time, for example ≥75% of labeled amount in 60 minutes.

FORMS TESTED

• Capsules
  
• Tablets