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Case Studies

Upperton Testing Method Enables Continued  Development of Drug Product 

Analytical Method Saves Dual-API Injectable Project From Stalling

Released By Upperton

The drug product consisted of two APIs combined in a molecular ratio of 2:1, in a spray dried formulation for reconstitution for sterile injection. 

Our challenge was to develop a single drug product analytical method to save our mid-sized client’s dual-API injectable project from stalling. Our challenge was also to support with formulation development, stability studies and clinical release. 

The method was required to be stability indicating and able to accurately quantify both API’s content and related substances. 

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