Laboratory Test Request

Chitosan Chewing Gum Accelerated Stability Study

Project Description

Medical Device Laboratory needed for accelerated stability studies of chitosan chewing gum. The product is packaged in an 8-count blister card. The stability testing will be used in a 510(K) medical device filing.

The accelerated stability specifications are:

- 50oC; 75%RH with 3 pulls at: 27 days (for 6 month dating); 54 days (for 1 year dating); 108 days (for two year dating)
- 40oC; 50%RH with 3 pulls at: 54 days (for 6 month dating); 108 days (for 1 year dating); 216 days (for two year dating)

Project Information

Number:22-02925

Industry:Medical Devices

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