Analytical Development

Analytical methods are a key element in the characterization of your product which will enable you to obtain important data such as stability, dissolution, shelf life, and other physio-chemical properties. Therefore, the development of analytical methods is conducted in parallel to the formulation development and ends only after the final formulation has been achieved. These methods will then be used to characterize the drug substance and drug product throughout their life cycle (whether in clinical or commercial stages).

​          Tip from our scientists

Before developing an analytical method, one must consider the intended use of the method and analytical instruments should be chosen accordingly. For example, a method used for quantitation of an active ingredient (API) in the drug product might not be suitable for quantitation of a much lower concentration in human blood and a different instrument might be required.

 

Services for you

  • Development and validation of methods for determination of the active material concentration in the finished product (Assay).

  • Development and validation of Stability Indicating Methods (SIM) including photostability, sensitivity to acidic or basic conditions, UV radiation, etc. using forced degradation studies.

  • Development and validation of methods for the detection of Impurities and Degradation products (ID).

  • Stability testing including storage in environmentally controlled chambers with 24/7 monitoring for all ICH climate conditions.

  • Development and validation of dissolution and drug release profiling methods.

  • Development and validation of Leachables and extractables methods (the study of potential materials resulting from the interaction between the drug product and its containers).

  • QC services (click here for the full QC tests list).

  • For a full list of our analytical instruments, click here.

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