Developing and Validating an HPLC Method
February 20, 2019
A host of resources must be harnessed to bring a drug to commercial launch. These include in-house development scientists, CROs and CMOs, all of whom are dependent upon reliable and reproducible data. This inevitably requires methods which generate high-quality results. Method development is a core capability at Averica. Our methods are robust, can be performed in-house by the client through the use of transferable technology, produce consistent results, and are aimed at deadline-oriented drug development processes.
Averica employs a unique method of developing HPLC methods to ensure that each research team can choose the right ones and achieve the right targets during drug development. This is just one of our services, read on to learn more, or visit our services pages to see our full range of capabilities.
ANALYTICAL TECHNIQUES FOR ANY PHASE OF A PRODUCT DEVELOPMENT PROJECT
We have developed analytical methods which are appropriate for any phase of product development. These include:
- Determining the purity of any specific impurity
- Assaying impurities for their potency
- Quantification of impurities
- Methods to assess chemical stability
- Methods to assay chiral purity or chiral bioanalytical methods
- Methods to help chemicals attain ICH Q11 standards, such as when regulated starting materials (RSMs) have to be qualified
- Analytical methods for molecules which have unique physical characteristics or structural complexity
- Methods to help modernize traditional or legacy testing techniques
- Methods to develop product specifications pending the commercial marketing of the product
METHODS THAT ARE APPROPRIATE FOR THE CLIENT AND THE MOLECULE
We are an independent company that specializes in the development and testing of analytical techniques. As such we target the emergence of methods that will benefit a drug development project.
Averica makes it a top priority to meet their clients’ need for highly dependable methods.
When a method is developed at Averica, it is fully tested, and each of the parameters that affect its performance as well as the critical quality attributes (CQA) are examined with attention. These include:
- The suitability of the system
- The limit of detection (LOD) and limit of quantitation (LOQ) respectively
- Linearity of the technique
- It’s precision
- The stability of the sample and of the standard
- The range of the testing method
- The mass balance
Our researchers work under the constraints of developing methods suited to the compound and we make sure the important method parameters and CQAs are properly defined and fully evaluated. Thus the methods developed by them are appropriate for their purpose, defined as to range, and capable of quick validation.
- Rapid method transfer
- Importance laid upon defining the method so that it can meet the client’s needs and fulfil the requirements of the development process
- Long experience with developing methods that are appropriate for difficult compounds and research programs
- Customized assays
- Testing of physical characteristics
- Extensive range of capabilities
OUR RANGE OF INSTRUMENT AND DETECTION SYSTEM
These include the following:
- Preparative and analytical in purpose – SFC, RPLC and HPLC
- CAD detection
- Accurate Mass MS
For more information and to explore our full range of capabilities, visit www.avericadiscovery.com/service.