Drug Product Analytical Services

Excipient Analysis

Excipients are essential to pharmaceutical formulations, influencing everything from stability to bioavailability.

Since many excipients are derived from natural sources, they often exhibit variability in purity, reactivity and functionality across different suppliers and even between batches. These inconsistencies can make it challenging to maintain control over product performance and safety.

Ofichem’s excipient characterisation expertise, helps identify critical properties to ensure consistent quality, safeguarding the efficacy and stability of your product.

Dissolution Testing

Dissolution testing is an essential tool in guiding pharmaceutical formulation development. Our team is dedicated to developing advanced predictive and biorelevant methods, empowering you to make well-informed R&D choices. These sophisticated methods allow our customers to proceed with clinical testing with confidence. We provide a complete range of dissolution apparatus, from Apparatus I and II to the more advanced Apparatus III and IV.

Reverse Engineering

Reverse engineering of drug products can significantly accelerate development by providing critical insights that help avoid certain clinical studies during product registration, speed up generic product development, address formulation challenges, and reveal valuable information about competitor formulations.

In addition to identifying formulation constituents, our team specialises in the precise quantification and qualification of excipients, including determining their grade, to deliver a comprehensive understanding of finished pharmaceutical products.